Trial Outcomes & Findings for Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I) (NCT NCT00106938)
NCT ID: NCT00106938
Last Updated: 2017-07-19
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1663 participants
Primary outcome timeframe
0 to 365 days
Results posted on
2017-07-19
Participant Flow
Asymptomatic subjects with extracranial internal carotid stenosis which was ≥70% \& ≤99% by duplex ultrasound or ≥70% \& ≤99% by angiography (visual estimate) with or without involvement of the contiguous common carotid artery, who could undergo carotid artery stenting/carotid endarterectomy and all follow-ups, were recruited starting from April 2005
1453 patients were randomized to support the primary analysis; an additional 210 lead-in subjects were enrolled to allow investigators to gain experience with the study devices prior to randomizing subjects and were not part of the primary analysis.
Participant milestones
| Measure |
CAS Group
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Overall Study
STARTED
|
1089
|
364
|
|
Overall Study
COMPLETED
|
913
|
293
|
|
Overall Study
NOT COMPLETED
|
176
|
71
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)
Baseline characteristics by cohort
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
Total
n=1453 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
325 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
428 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
764 Participants
n=5 Participants
|
261 Participants
n=7 Participants
|
1025 Participants
n=5 Participants
|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
67.7 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
423 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
580 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
666 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
873 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
985 participants
n=5 Participants
|
327 participants
n=7 Participants
|
1312 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
38 participants
n=5 Participants
|
12 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
45 participants
n=5 Participants
|
16 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 participants
n=5 Participants
|
4 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 participants
n=5 Participants
|
4 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1089 participants
n=5 Participants
|
364 participants
n=7 Participants
|
1453 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 365 daysOutcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days.
|
3.8 percentage of participants
|
3.4 percentage of participants
|
SECONDARY outcome
Timeframe: On day 0 after index procedurePopulation: Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.
Defined as attainment of final residual diameter stenosis of \< 50% by Qualitative Comparative Analysis (QCA) (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.
Outcome measures
| Measure |
CAS Group
n=1049 devices
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Acute Device Success: Xact Carotid Stent
|
96.9 percentage of devices
Interval 95.6 to 97.8
|
—
|
SECONDARY outcome
Timeframe: On day 0 after index procedurePopulation: Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.
Defined as successful deployment and retrieval of the filter in the absence of angiographic distal embolization.
Outcome measures
| Measure |
CAS Group
n=1045 Devices
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Acute Device Success: Embolic Protection Device System
|
97.8 Percentage of devices
Interval 96.7 to 98.6
|
—
|
SECONDARY outcome
Timeframe: 0 to 30 days post procedurePopulation: The analysis population is Procedure success is per subject basis including the attempted CAS (carotid artery stenting) procedure only. CEA group is not part of analysis population for procedure success.
Procedural success is defined as the attainment of target lesion final residual diameter stenosis of \< 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) using any procedural method and freedom of Major Adverse Event at 30 days.
Outcome measures
| Measure |
CAS Group
n=1025 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Procedural Success
|
95.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 0 to 30 Days Post-procedurePopulation: Intent-to-Treat (ITT) population
A pre-specified composite Morbidity Measure (CMM) of cranial and peripheral nerve injury, vascular injury, non-cerebral bleeding, wound complications related to the neck incision or femoral puncture site, and other complications (anesthetic) at 30 days post-procedure.
Outcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Composite Morbidity Measure
Composite morbidity measure
|
31 participants
|
17 participants
|
|
Composite Morbidity Measure
Cranial nerve injury
|
1 participants
|
4 participants
|
|
Composite Morbidity Measure
Non-cerebral bleeding
|
21 participants
|
6 participants
|
|
Composite Morbidity Measure
Peripheral nerve injury
|
0.0 participants
|
0.0 participants
|
|
Composite Morbidity Measure
Vascular injury
|
8 participants
|
3 participants
|
|
Composite Morbidity Measure
CEA wound or access artery wound
|
3 participants
|
4 participants
|
|
Composite Morbidity Measure
Other complications
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 to 180 daysFreedom from CI-TLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Outcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)
|
99.8 percentage of partcipants
|
99.7 percentage of partcipants
|
SECONDARY outcome
Timeframe: 0 to 365 daysFreedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Outcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Clinically Indicated Target Lesion Revascularization
|
99.4 percentage of partcipants
|
97.4 percentage of partcipants
|
SECONDARY outcome
Timeframe: 0 to 730 daysFreedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Outcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Clinically Indicated Target Lesion Revascularization
|
98.7 percentage of partcipants
|
96.7 percentage of partcipants
|
SECONDARY outcome
Timeframe: 0 to 1095 daysFreedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Outcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Clinically Indicated Target Lesion Revascularization
|
98.4 percentage of partcipants
|
96.7 percentage of partcipants
|
SECONDARY outcome
Timeframe: 0 to 1460 daysFreedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Outcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Clinically Indicated Target Lesion Revascularization
|
98.4 percentage of partcipants
|
96.7 percentage of partcipants
|
SECONDARY outcome
Timeframe: 0 to 1825 daysFreedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Outcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Clinically Indicated Target Lesion Revascularization
|
98.4 percentage of partcipants
|
96.7 percentage of partcipants
|
SECONDARY outcome
Timeframe: 31 to 365 daysIpsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Outcome measures
| Measure |
CAS Group
n=1049 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=333 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Ipsilateral Stroke
|
99.4 percentage of participants
|
99.1 percentage of participants
|
SECONDARY outcome
Timeframe: 31 to 730 daysIpsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Outcome measures
| Measure |
CAS Group
n=1049 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=333 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Ipsilateral Stroke
|
99.0 percentage of participants
|
98.7 percentage of participants
|
SECONDARY outcome
Timeframe: 31 to 1095 daysIpsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Outcome measures
| Measure |
CAS Group
n=1049 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=333 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Ipsilateral Stroke
|
98.4 percentage of participants
|
97.8 percentage of participants
|
SECONDARY outcome
Timeframe: 31 to 1460 daysIpsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Outcome measures
| Measure |
CAS Group
n=1049 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=333 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Ipsilateral Stroke
|
97.8 percentage of participants
|
97.3 percentage of participants
|
SECONDARY outcome
Timeframe: 31 to 1825 daysIpsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Outcome measures
| Measure |
CAS Group
n=1049 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=333 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Ipsilateral Stroke
|
97.8 percentage of participants
|
97.3 percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 365 daysOutcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Mortality
|
98.5 percentage of participants
|
99.1 percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 730 daysOutcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Mortality
|
96.2 percentage of participants
|
98.4 percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 1095 daysOutcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Mortality
|
94.3 percentage of partcipants
|
97.5 percentage of partcipants
|
SECONDARY outcome
Timeframe: 0 to 1460 daysOutcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Mortality
|
91.5 percentage of participants
|
93.7 percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 1825 daysOutcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Mortality
|
87.1 percentage of participants
|
89.4 percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 365 daysOutcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From All Stroke
|
96.5 percentage of participants
|
97.7 percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 730 daysOutcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From All Stroke
|
95.8 percentage of participants
|
96.2 percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 1095 daysOutcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From All Stroke
|
94.5 percentage of participants
|
95.3 percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 1460 daysOutcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From All Stroke
|
93.8 percentage of participants
|
94.7 percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 1825 daysOutcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From All Stroke
|
93.1 percentage of participants
|
94.7 percentage of participants
|
SECONDARY outcome
Timeframe: ≤ 30 Days Post Index ProcedurePopulation: Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.
Outcome measures
| Measure |
CAS Group
n=1072 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=348 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Death (Non-Hierarchical)
|
0.1 percentage of participants
Interval 0.0 to 0.5
|
0.3 percentage of participants
Interval 0.0 to 1.6
|
SECONDARY outcome
Timeframe: ≤ 30 Days Post Index ProcedurePopulation: Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.
Outcome measures
| Measure |
CAS Group
n=1072 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=348 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
All Stroke (Non-Hierarchical)
|
2.8 percentage of participants
Interval 1.9 to 4.0
|
1.4 percentage of participants
Interval 0.5 to 3.3
|
SECONDARY outcome
Timeframe: ≤ 30 Days Post Index ProcedurePopulation: Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.
Outcome measures
| Measure |
CAS Group
n=1072 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=348 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Myocardial Infarction (MI) (Non-Hierarchical)
|
0.5 percentage of participants
Interval 0.2 to 1.1
|
0.9 percentage of participants
Interval 0.2 to 2.5
|
SECONDARY outcome
Timeframe: ≤ 30 Days Post Index ProcedurePopulation: Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.
Outcome measures
| Measure |
CAS Group
n=1072 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=348 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Death, Stroke or Myocardial Infarction (MI) (Hierarchical)
|
3.3 percentage of participants
Interval 2.3 to 4.5
|
2.6 percentage of participants
Interval 1.2 to 4.9
|
SECONDARY outcome
Timeframe: ≤ 30 Days Post Index ProcedurePopulation: Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.
Outcome measures
| Measure |
CAS Group
n=1072 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=348 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Death or Stroke (Hierarchical)
|
2.9 percentage of participants
Interval 2.0 to 4.1
|
1.7 percentage of participants
Interval 0.6 to 3.7
|
SECONDARY outcome
Timeframe: ≤ 30 Days Post Index ProcedurePopulation: Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.
Outcome measures
| Measure |
CAS Group
n=1072 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=348 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Death or Major Stroke (Hierarchical)
|
0.6 percentage of participants
Interval 0.2 to 1.2
|
0.6 percentage of participants
Interval 0.1 to 2.1
|
SECONDARY outcome
Timeframe: 0 to 5 yearsOutcome measures
| Measure |
CAS Group
n=1089 Participants
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 Participants
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years
|
94.6 percentage of participants
|
94.8 percentage of participants
|
Adverse Events
CAS Group
Serious events: 376 serious events
Other events: 635 other events
Deaths: 0 deaths
CEA Group
Serious events: 118 serious events
Other events: 216 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAS Group
n=1089 participants at risk
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 participants at risk
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Bleeding
|
0.64%
7/1089 • Number of events 8 • 1 year
|
0.82%
3/364 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Hematoma
|
0.37%
4/1089 • Number of events 4 • 1 year
|
0.82%
3/364 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Infection
|
0.28%
3/1089 • Number of events 6 • 1 year
|
0.82%
3/364 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Occlusion
|
0.18%
2/1089 • Number of events 2 • 1 year
|
0.00%
0/364 • 1 year
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Injury, poisoning and procedural complications
Vessel trauma
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Blood and lymphatic system disorders
Epistaxis
|
0.18%
2/1089 • Number of events 2 • 1 year
|
0.00%
0/364 • 1 year
|
|
Blood and lymphatic system disorders
GI bleed
|
1.4%
15/1089 • Number of events 15 • 1 year
|
2.2%
8/364 • Number of events 8 • 1 year
|
|
Blood and lymphatic system disorders
Genitourinary
|
0.18%
2/1089 • Number of events 2 • 1 year
|
0.00%
0/364 • 1 year
|
|
Blood and lymphatic system disorders
Vascular
|
0.00%
0/1089 • 1 year
|
0.55%
2/364 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
1.2%
13/1089 • Number of events 15 • 1 year
|
0.82%
3/364 • Number of events 3 • 1 year
|
|
Cardiac disorders
Abnormal lab test
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
2.0%
22/1089 • Number of events 25 • 1 year
|
1.1%
4/364 • Number of events 5 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
0.46%
5/1089 • Number of events 5 • 1 year
|
0.82%
3/364 • Number of events 3 • 1 year
|
|
Cardiac disorders
Congestive heart failure
|
0.92%
10/1089 • Number of events 12 • 1 year
|
0.27%
1/364 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
5.2%
57/1089 • Number of events 70 • 1 year
|
5.8%
21/364 • Number of events 25 • 1 year
|
|
Cardiac disorders
Pulmonary hypertension
|
0.18%
2/1089 • Number of events 2 • 1 year
|
0.00%
0/364 • 1 year
|
|
Cardiac disorders
Structural heart disease
|
0.18%
2/1089 • Number of events 2 • 1 year
|
0.00%
0/364 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
14/1089 • Number of events 16 • 1 year
|
1.4%
5/364 • Number of events 5 • 1 year
|
|
Vascular disorders
Hypertension
|
0.55%
6/1089 • Number of events 6 • 1 year
|
0.55%
2/364 • Number of events 2 • 1 year
|
|
Vascular disorders
Hypotension
|
0.64%
7/1089 • Number of events 8 • 1 year
|
0.27%
1/364 • Number of events 1 • 1 year
|
|
Vascular disorders
Syncope
|
0.37%
4/1089 • Number of events 4 • 1 year
|
0.27%
1/364 • Number of events 1 • 1 year
|
|
Nervous system disorders
Confusion
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Nervous system disorders
Cranial nerve palsy
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.82%
3/364 • Number of events 3 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1089 • 1 year
|
0.27%
1/364 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Nervous system disorders
Hyperperfusion syndrome
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Nervous system disorders
Neurologic other
|
1.2%
13/1089 • Number of events 13 • 1 year
|
0.82%
3/364 • Number of events 5 • 1 year
|
|
Nervous system disorders
Peripheral neuropathy
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Nervous system disorders
Seizure
|
0.46%
5/1089 • Number of events 7 • 1 year
|
0.27%
1/364 • Number of events 1 • 1 year
|
|
Nervous system disorders
Subdural hematoma
|
0.18%
2/1089 • Number of events 2 • 1 year
|
0.00%
0/364 • 1 year
|
|
Nervous system disorders
TIA
|
0.64%
7/1089 • Number of events 8 • 1 year
|
0.55%
2/364 • Number of events 2 • 1 year
|
|
Nervous system disorders
Visual disturbance
|
0.28%
3/1089 • Number of events 3 • 1 year
|
0.00%
0/364 • 1 year
|
|
Nervous system disorders
Ipsilateral major
|
0.64%
7/1089 • Number of events 7 • 1 year
|
0.27%
1/364 • Number of events 1 • 1 year
|
|
Nervous system disorders
Ipsilateral minor
|
1.8%
20/1089 • Number of events 20 • 1 year
|
1.6%
6/364 • Number of events 6 • 1 year
|
|
Nervous system disorders
Non-ipsilateral major
|
0.18%
2/1089 • Number of events 2 • 1 year
|
0.00%
0/364 • 1 year
|
|
Nervous system disorders
Non-ipsilateral minor
|
0.28%
3/1089 • Number of events 3 • 1 year
|
0.00%
0/364 • 1 year
|
|
Surgical and medical procedures
Anesthesia/Procedural medication related
|
0.00%
0/1089 • 1 year
|
0.55%
2/364 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Arrhythmia
|
1.6%
17/1089 • Number of events 18 • 1 year
|
0.82%
3/364 • Number of events 3 • 1 year
|
|
Surgical and medical procedures
Bleeding
|
1.0%
11/1089 • Number of events 11 • 1 year
|
0.00%
0/364 • 1 year
|
|
Surgical and medical procedures
Cranial nerve injury
|
0.18%
2/1089 • Number of events 2 • 1 year
|
0.82%
3/364 • Number of events 3 • 1 year
|
|
Surgical and medical procedures
Fluid overload
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Surgical and medical procedures
Headache
|
0.00%
0/1089 • 1 year
|
0.27%
1/364 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Heparin induced thrombocytopenia
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Surgical and medical procedures
Hypertension
|
0.46%
5/1089 • Number of events 6 • 1 year
|
1.9%
7/364 • Number of events 7 • 1 year
|
|
Surgical and medical procedures
Hypotension
|
6.3%
69/1089 • Number of events 69 • 1 year
|
1.9%
7/364 • Number of events 7 • 1 year
|
|
Surgical and medical procedures
Spasm
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Surgical and medical procedures
Urinary retention
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.55%
2/364 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Vessel trauma
|
0.64%
7/1089 • Number of events 7 • 1 year
|
0.00%
0/364 • 1 year
|
|
Vascular disorders
Abdominal Aortic Aneurysm
|
0.18%
2/1089 • Number of events 2 • 1 year
|
0.55%
2/364 • Number of events 2 • 1 year
|
|
Vascular disorders
Carotid artery disease
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Vascular disorders
Contralateral stenosis
|
0.64%
7/1089 • Number of events 7 • 1 year
|
0.82%
3/364 • Number of events 3 • 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1089 • 1 year
|
0.27%
1/364 • Number of events 1 • 1 year
|
|
Vascular disorders
Occlusion
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Vascular disorders
Peripheral vascular disease
|
3.8%
41/1089 • Number of events 56 • 1 year
|
3.0%
11/364 • Number of events 20 • 1 year
|
|
Vascular disorders
Pulmonary embolism
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Vascular disorders
Renal artery disease
|
0.92%
10/1089 • Number of events 10 • 1 year
|
0.27%
1/364 • Number of events 1 • 1 year
|
|
Vascular disorders
Restenosis
|
0.09%
1/1089 • Number of events 1 • 1 year
|
0.00%
0/364 • 1 year
|
|
Vascular disorders
Stenosis
|
0.28%
3/1089 • Number of events 3 • 1 year
|
0.27%
1/364 • Number of events 1 • 1 year
|
|
Vascular disorders
Target lesion restenosis
|
0.73%
8/1089 • Number of events 8 • 1 year
|
2.5%
9/364 • Number of events 10 • 1 year
|
|
Immune system disorders
Allergic reaction
|
0.18%
2/1089 • Number of events 2 • 1 year
|
0.00%
0/364 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.9%
21/1089 • Number of events 23 • 1 year
|
2.2%
8/364 • Number of events 10 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.7%
29/1089 • Number of events 39 • 1 year
|
0.82%
3/364 • Number of events 3 • 1 year
|
|
General disorders
Genitourinary
|
2.3%
25/1089 • Number of events 28 • 1 year
|
0.27%
1/364 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection
|
2.1%
23/1089 • Number of events 25 • 1 year
|
1.6%
6/364 • Number of events 6 • 1 year
|
|
Psychiatric disorders
Mental health related
|
0.37%
4/1089 • Number of events 4 • 1 year
|
0.55%
2/364 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Metabolic
|
0.92%
10/1089 • Number of events 10 • 1 year
|
0.27%
1/364 • Number of events 1 • 1 year
|
|
General disorders
Miscellaneous
|
1.3%
14/1089 • Number of events 14 • 1 year
|
1.1%
4/364 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
3.8%
41/1089 • Number of events 45 • 1 year
|
1.9%
7/364 • Number of events 7 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
1.7%
19/1089 • Number of events 24 • 1 year
|
2.5%
9/364 • Number of events 9 • 1 year
|
|
General disorders
Trauma
|
1.2%
13/1089 • Number of events 15 • 1 year
|
1.6%
6/364 • Number of events 6 • 1 year
|
Other adverse events
| Measure |
CAS Group
n=1089 participants at risk
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
CEA Group
n=364 participants at risk
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Anesthesia/Procedural medication related
|
6.0%
65/1089 • Number of events 70 • 1 year
|
14.0%
51/364 • Number of events 55 • 1 year
|
|
Injury, poisoning and procedural complications
Arrhythmia
|
12.9%
140/1089 • Number of events 148 • 1 year
|
5.5%
20/364 • Number of events 20 • 1 year
|
|
Injury, poisoning and procedural complications
Cranial nerve injury
|
1.3%
14/1089 • Number of events 15 • 1 year
|
13.2%
48/364 • Number of events 51 • 1 year
|
|
Injury, poisoning and procedural complications
Headache
|
6.7%
73/1089 • Number of events 74 • 1 year
|
8.2%
30/364 • Number of events 31 • 1 year
|
|
Injury, poisoning and procedural complications
Hypertension
|
3.7%
40/1089 • Number of events 40 • 1 year
|
8.0%
29/364 • Number of events 29 • 1 year
|
|
Injury, poisoning and procedural complications
Hypotension
|
23.1%
252/1089 • Number of events 268 • 1 year
|
9.6%
35/364 • Number of events 36 • 1 year
|
|
Injury, poisoning and procedural complications
Pain
|
5.1%
56/1089 • Number of events 60 • 1 year
|
17.6%
64/364 • Number of events 66 • 1 year
|
|
Gastrointestinal disorders
Other
|
8.5%
93/1089 • Number of events 115 • 1 year
|
9.1%
33/364 • Number of events 41 • 1 year
|
|
Infections and infestations
Other
|
7.4%
81/1089 • Number of events 92 • 1 year
|
6.3%
23/364 • Number of events 31 • 1 year
|
|
Metabolism and nutrition disorders
Other
|
4.7%
51/1089 • Number of events 58 • 1 year
|
6.6%
24/364 • Number of events 25 • 1 year
|
|
General disorders
Other
|
9.8%
107/1089 • Number of events 140 • 1 year
|
11.0%
40/364 • Number of events 47 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Other
|
15.9%
173/1089 • Number of events 211 • 1 year
|
7.7%
28/364 • Number of events 36 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
5.1%
56/1089 • Number of events 66 • 1 year
|
4.9%
18/364 • Number of events 20 • 1 year
|
Additional Information
Jennifer M Jones-McMeans, PhD (Associate Director Clinical Research)
Abbott Vascular
Phone: 408-845-1459
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60