Trial Outcomes & Findings for Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1 (NCT NCT02777528)
NCT ID: NCT02777528
Last Updated: 2025-06-25
Results Overview
Primary Endpoint was composite of the following events from the time of enrollment through one month following the endovascular procedure (through day 59 unless otherwise specified): initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure and absence of aortic rupture, lesion related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
1 month
Results posted on
2025-06-25
Participant Flow
The study enrolled participants into 2 Zones (7 total cohorts) and results are reported by zone. This record (NCT02777528) contains the results for the 3 cohorts of Zone 0/1 (Zone 0/1 Aneurysm Cohort, Zone 0/1 Dissection Cohort, Zone 0/1 Other Isolated Lesion Cohort). Results for the 4 cohorts of Zone 2 (Zone 2 Aneurysm Cohort, Zone 2 Dissection Cohort, Zone 2 Other Lesions Cohort, Zone 2 Traumatic Transection Cohort) are reported in a separate record (NCT02777593).
Participant milestones
| Measure |
Zone 0/1 Aneurysm Cohort
Aneurysm arm, hypothesis-driven cohort
|
Zone 0/1 Dissection Cohort
Non-aneurysm arm, dissection cohort
|
Zone 0/1 Other Isolated Lesion Cohort
Non-aneurysm arm, other isolated lesion cohort
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
24
|
3
|
|
Overall Study
Analysis Population
|
50
|
24
|
3
|
|
Overall Study
COMPLETED
|
6
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
46
|
20
|
3
|
Reasons for withdrawal
| Measure |
Zone 0/1 Aneurysm Cohort
Aneurysm arm, hypothesis-driven cohort
|
Zone 0/1 Dissection Cohort
Non-aneurysm arm, dissection cohort
|
Zone 0/1 Other Isolated Lesion Cohort
Non-aneurysm arm, other isolated lesion cohort
|
|---|---|---|---|
|
Overall Study
Still in study
|
24
|
10
|
1
|
|
Overall Study
Study Device Explanted
|
1
|
0
|
0
|
|
Overall Study
Death
|
14
|
7
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
|
Overall Study
Discontinued due to Other
|
1
|
0
|
0
|
Baseline Characteristics
Site was queried and the weight for one Zone 0/1 Aneurysm Subject is unavailable.
Baseline characteristics by cohort
| Measure |
Zone 0/1 Aneurysm Cohort
n=50 Participants
Aneurysm arm, hypothesis-driven cohort
|
Zone 0/1 Dissection Cohort
n=24 Participants
Non-aneurysm arm, dissection cohort
|
Zone 0/1 Other Isolated Lesion Cohort
n=3 Participants
Non-aneurysm arm, other isolated lesion cohort
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
74.3 years
STANDARD_DEVIATION 8.56 • n=50 Participants
|
63.0 years
STANDARD_DEVIATION 11.31 • n=24 Participants
|
73.7 years
STANDARD_DEVIATION 9.02 • n=3 Participants
|
70.8 years
STANDARD_DEVIATION 10.75 • n=77 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=50 Participants
|
7 Participants
n=24 Participants
|
1 Participants
n=3 Participants
|
26 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=50 Participants
|
17 Participants
n=24 Participants
|
2 Participants
n=3 Participants
|
51 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=50 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=50 Participants
|
23 Participants
n=24 Participants
|
3 Participants
n=3 Participants
|
73 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=77 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=50 Participants
|
13 Participants
n=24 Participants
|
3 Participants
n=3 Participants
|
43 Participants
n=77 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=50 Participants
|
6 Participants
n=24 Participants
|
0 Participants
n=3 Participants
|
12 Participants
n=77 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 Participants
n=50 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=3 Participants
|
18 Participants
n=77 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=50 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=77 Participants
|
|
Race/Ethnicity, Customized
Hawaiian or Pacific Islander
|
1 Participants
n=50 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=77 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=50 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=77 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=50 Participants
|
23 participants
n=24 Participants
|
3 participants
n=3 Participants
|
66 participants
n=77 Participants
|
|
Region of Enrollment
Japan
|
10 participants
n=50 Participants
|
1 participants
n=24 Participants
|
0 participants
n=3 Participants
|
11 participants
n=77 Participants
|
|
BMI
|
27.3 kg/m^2
STANDARD_DEVIATION 5.94 • n=49 Participants • Site was queried and the weight for one Zone 0/1 Aneurysm Subject is unavailable.
|
29.9 kg/m^2
STANDARD_DEVIATION 4.44 • n=24 Participants • Site was queried and the weight for one Zone 0/1 Aneurysm Subject is unavailable.
|
23.4 kg/m^2
STANDARD_DEVIATION 2.01 • n=3 Participants • Site was queried and the weight for one Zone 0/1 Aneurysm Subject is unavailable.
|
27.9 kg/m^2
STANDARD_DEVIATION 5.57 • n=76 Participants • Site was queried and the weight for one Zone 0/1 Aneurysm Subject is unavailable.
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Two Zone 0/1 Aneurysm participants that are counted in the Participant Flow section above are excluded from this analysis, as pre-specified due to treatment with 49/53 mm devices no longer supported by the protocol. Primary Endpoint composite denominator was restricted to number of participants either with a primary endpoint event or imaging performed in the 1 Month window.
Primary Endpoint was composite of the following events from the time of enrollment through one month following the endovascular procedure (through day 59 unless otherwise specified): initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure and absence of aortic rupture, lesion related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
Outcome measures
| Measure |
Zone 0/1 Aneurysm Cohort
n=47 Participants
Aneurysm arm, hypothesis-driven cohort
|
Zone 0/1 Dissection Cohort
n=22 Participants
Non-aneurysm arm, dissection cohort
|
Zone 0/1 Other Isolated Lesion Cohort
n=3 Participants
Non-aneurysm arm, other isolated lesion cohort
|
|---|---|---|---|
|
Proportion of Participants With Primary Endpoint Success Through 1 Month for Zone 0/1
|
0.745 proportion of participants
|
0.818 proportion of participants
|
1.0 proportion of participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Two Zone 0/1 Aneurysm participants that are counted in the Participant Flow section above are excluded from this analysis, as pre-specified, due to treatment with 49/53 devices no longer supported by the protocol. Primary Endpoint composite denominator was restricted to number of participants either with a primary endpoint event or imaging performed in the 12 Month window.
Primary Endpoint was composite of the following events from the time of enrollment through twelve months following the endovascular procedure: initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure and absence of aortic rupture, lesion related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
Outcome measures
| Measure |
Zone 0/1 Aneurysm Cohort
n=44 Participants
Aneurysm arm, hypothesis-driven cohort
|
Zone 0/1 Dissection Cohort
n=24 Participants
Non-aneurysm arm, dissection cohort
|
Zone 0/1 Other Isolated Lesion Cohort
n=2 Participants
Non-aneurysm arm, other isolated lesion cohort
|
|---|---|---|---|
|
Proportion of Participants With Primary Endpoint Success Through 12 Months for Zone 0/1
|
0.727 proportion of participants
|
0.750 proportion of participants
|
1.0 proportion of participants
|
Adverse Events
Zone 0/1 Aneurysm Cohort
Serious events: 43 serious events
Other events: 40 other events
Deaths: 14 deaths
Zone 0/1 Dissection Cohort
Serious events: 19 serious events
Other events: 21 other events
Deaths: 7 deaths
Zone 0/1 Other Isolated Lesion Cohort
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Zone 0/1 Aneurysm Cohort
n=52 participants at risk
Aneurysm arm, hypothesis-driven cohort
|
Zone 0/1 Dissection Cohort
n=24 participants at risk
Non-aneurysm arm, dissection cohort
|
Zone 0/1 Other Isolated Lesion Cohort
n=3 participants at risk
Non-aneurysm arm, other isolated lesion cohort
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Acute blood loss anemia
|
1.9%
1/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Blood and lymphatic system disorders
Anemia aggravated
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Acute systolic heart failure
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Aortic regurgitation
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Aortic valve insufficiency
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Asystole
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Cardiogenic shock
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Cardiomyopathy
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Complete heart block
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Congestive cardiac failure aggravated
|
1.9%
1/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Congestive heart failure
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Heart failure
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Left ventricular dysfunction
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Non ST segment elevation myocardial infarction
|
5.8%
3/52 • Number of events 3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Pericardial effusion malignant
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Pulseless electrical activity
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Stress cardiomyopathy
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Systolic heart failure
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Eye disorders
Right cataract
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Eye disorders
Vision loss
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Alcoholic gastritis, without mention of hemorrhage
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Aortoenteric fistula
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Bleeding gastric ulcer
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
GI bleed
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Mesenteric ischemia
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Retroperitoneal hematoma
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Upper gastrointestinal bleeding
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Fever
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Multi-organ failure
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Puncture site bleeding
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Stent-graft endoleak type IA
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Stent-graft endoleak type IB
|
7.7%
4/52 • Number of events 4 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Stent-graft endoleak type II
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Stent-graft endoleak type IIIA
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Unknown cause of death
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Hepatobiliary disorders
Alcoholic hepatitis
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Aspiration pneumonia
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Bacteremia
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Bilateral pneumonia
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Diarrhea, Clostridium difficile
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Gram-positive bacteremia
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Hospital acquired pneumonia
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Infective aortitis
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Inguinal abscess
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Klebsiella septicemia
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Nosocomial pneumonia
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Obstructive pneumonia
|
1.9%
1/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Periapical dental abscess
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Pneumonia
|
7.7%
4/52 • Number of events 6 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Pneumonia aggravated
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Sepsis
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Septic shock
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Vascular graft infection
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Vascular stent graft infection
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Alcohol intoxication
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Bladder injury
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Bypass graft occlusion
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Bypass graft stenosis
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Femoral artery pseudoaneurysm
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Fracture of one or more phalanges of hand, open
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Incision site hematoma
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Intertrochanteric femoral fracture
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Intraoperative bleeding
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Intraoperative venous injury
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Post spinal headache
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Procedural bleeding
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Injury, poisoning and procedural complications
Tongue laceration
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Musculoskeletal and connective tissue disorders
Degenerative arthritis peripheral joint
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Musculoskeletal and connective tissue disorders
Knee arthritis
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis knees
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Appendix cancer
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Brain injury
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Carotid artery dissection
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Cerebral infarct
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Cerebral infarction
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Embolic stroke
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Ischemic stroke
|
5.8%
3/52 • Number of events 3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Paralysis vocal cord
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Stroke
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Vocal cord paralysis
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Product Issues
Catheter breakage
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Psychiatric disorders
Mental status changes
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Renal and urinary disorders
Acute renal failure
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Renal and urinary disorders
Renal disease
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Renal and urinary disorders
Renal failure aggravated
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Renal and urinary disorders
Renal hemorrhage
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Renal and urinary disorders
Uremia
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Renal and urinary disorders
Urinary bladder hematoma
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxic respiratory failure
|
9.6%
5/52 • Number of events 5 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Acute on chronic respiratory failure
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pleural effusion
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease exacerbation
|
9.6%
5/52 • Number of events 5 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnic respiratory failure
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Increased shortness of breath
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fistula
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.8%
3/52 • Number of events 4 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Aortic rupture
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Arterial occlusion
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Blood loss of (NOS)
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Blue toe syndrome
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Deep vein thrombosis leg
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Descending thoracic aorta rupture
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Descending thoracic aortic aneurysm enlargement
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Dissecting aneurysm of aorta
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Femoral artery dissection
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Hematoma
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Hypotension
|
5.8%
3/52 • Number of events 3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Hypovolemic shock
|
1.9%
1/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Iliac artery dissection
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Iliac artery rupture
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Iliac artery stenosis
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Leg ischemia
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Low blood pressure
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Orthostatic hypotension
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Shock
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
Other adverse events
| Measure |
Zone 0/1 Aneurysm Cohort
n=52 participants at risk
Aneurysm arm, hypothesis-driven cohort
|
Zone 0/1 Dissection Cohort
n=24 participants at risk
Non-aneurysm arm, dissection cohort
|
Zone 0/1 Other Isolated Lesion Cohort
n=3 participants at risk
Non-aneurysm arm, other isolated lesion cohort
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Acute post hemorrhagic anemia
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Blood and lymphatic system disorders
Anemia
|
9.6%
5/52 • Number of events 5 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.8%
3/52 • Number of events 3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.8%
3/52 • Number of events 3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Constipation
|
5.8%
3/52 • Number of events 3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Dysphagia
|
5.8%
3/52 • Number of events 3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Fever
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Non-cardiac chest pain
|
5.8%
3/52 • Number of events 6 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Stent-graft endoleak
|
3.8%
2/52 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Stent-graft endoleak type II
|
17.3%
9/52 • Number of events 9 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
General disorders
Weakness generalized
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Arteriovenous graft site cellulitis
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
COVID-19
|
11.5%
6/52 • Number of events 6 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Infections and infestations
Urinary tract infection
|
11.5%
6/52 • Number of events 8 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Metabolism and nutrition disorders
Appetite lost
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Headache
|
5.8%
3/52 • Number of events 3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
4.2%
1/24 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Seizure
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Nervous system disorders
Transient hemiparesis
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Renal and urinary disorders
Acute kidney injury
|
9.6%
5/52 • Number of events 5 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness of voice
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Ascending aortic aneurysm enlargement
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Groin hematoma
|
1.9%
1/52 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Hypotension
|
13.5%
7/52 • Number of events 8 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
8.3%
2/24 • Number of events 2 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/3 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
|
Vascular disorders
Iliac artery dissection
|
0.00%
0/52 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
0.00%
0/24 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded Zone 0/1 Aneurysm participants, due to treatment with 49/53 mm device no longer supported by the protocol, have been included in this Adverse Events section. Collection starting at revascularization procedure. Adverse event data collection is still ongoing and will be updated upon study completion. As described in the Participant Flow Section, the study reports results in 2 separate records. Zone 2 cohorts are reported in record NCT02777593.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place