Trial Outcomes & Findings for Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices (NCT NCT02407457)
NCT ID: NCT02407457
Last Updated: 2024-10-01
Results Overview
ARC is a composite of the most relevant EVAR outcomes and includes: * Peri-Operative Death (\< 30 days) * Rupture * Conversion to OSR * Endoleaks; post-operative * Migration (≥ 10mm) * Aneurysm Enlargement (≥ 5mm) * Endograft Limb Occlusions * Reinterventions for device- or aneurysm-related complications
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
455 participants
Primary outcome timeframe
1 year
Results posted on
2024-10-01
Participant Flow
Participant milestones
| Measure |
AFX EVAR AAA Graft System
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Baseline
STARTED
|
235
|
220
|
|
Baseline
COMPLETED
|
235
|
220
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
1 Month
STARTED
|
235
|
220
|
|
1 Month
COMPLETED
|
229
|
214
|
|
1 Month
NOT COMPLETED
|
6
|
6
|
|
6-Month
STARTED
|
231
|
219
|
|
6-Month
COMPLETED
|
211
|
194
|
|
6-Month
NOT COMPLETED
|
20
|
25
|
|
1 Year
STARTED
|
227
|
208
|
|
1 Year
COMPLETED
|
194
|
180
|
|
1 Year
NOT COMPLETED
|
33
|
28
|
|
2-year
STARTED
|
218
|
194
|
|
2-year
COMPLETED
|
184
|
159
|
|
2-year
NOT COMPLETED
|
34
|
35
|
|
3-year
STARTED
|
197
|
174
|
|
3-year
COMPLETED
|
158
|
138
|
|
3-year
NOT COMPLETED
|
39
|
36
|
|
4-year
STARTED
|
177
|
133
|
|
4-year
COMPLETED
|
131
|
95
|
|
4-year
NOT COMPLETED
|
46
|
38
|
|
5-year
STARTED
|
148
|
131
|
|
5-year
COMPLETED
|
107
|
114
|
|
5-year
NOT COMPLETED
|
41
|
17
|
Reasons for withdrawal
| Measure |
AFX EVAR AAA Graft System
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
1 Month
Death
|
3
|
0
|
|
1 Month
Lost to Follow-up
|
1
|
1
|
|
1 Month
missed visit
|
2
|
5
|
|
6-Month
Death
|
2
|
8
|
|
6-Month
Lost to Follow-up
|
2
|
2
|
|
6-Month
missed visit
|
16
|
14
|
|
6-Month
Open Repair
|
0
|
1
|
|
1 Year
Death
|
6
|
11
|
|
1 Year
Lost to Follow-up
|
3
|
2
|
|
1 Year
Missed Visit
|
24
|
14
|
|
1 Year
Open Repair
|
0
|
1
|
|
2-year
Death
|
14
|
8
|
|
2-year
Lost to Follow-up
|
7
|
10
|
|
2-year
Missed Visit
|
13
|
15
|
|
2-year
Open Repair
|
0
|
2
|
|
3-year
Death
|
11
|
10
|
|
3-year
Lost to Follow-up
|
9
|
10
|
|
3-year
Missed Visit
|
19
|
16
|
|
4-year
Death
|
18
|
10
|
|
4-year
Lost to Follow-up
|
10
|
12
|
|
4-year
Missed Visit
|
18
|
16
|
|
5-year
Death
|
10
|
3
|
|
5-year
Lost to Follow-up
|
22
|
13
|
|
5-year
Missed Visit
|
9
|
1
|
Baseline Characteristics
Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
Baseline characteristics by cohort
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 8 • n=5 Participants
|
72 years
STANDARD_DEVIATION 8 • n=7 Participants
|
72 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
404 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
225 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
424 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-caucasian
|
10 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
ASA Classification
ASA Class 1/2
|
71 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
ASA Classification
ASA Class 3/4/5
|
164 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearARC is a composite of the most relevant EVAR outcomes and includes: * Peri-Operative Death (\< 30 days) * Rupture * Conversion to OSR * Endoleaks; post-operative * Migration (≥ 10mm) * Aneurysm Enlargement (≥ 5mm) * Endograft Limb Occlusions * Reinterventions for device- or aneurysm-related complications
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Number of Patients With Absence of Aneurysm Related Complications (ARC)
|
195 Participants
|
175 Participants
|
SECONDARY outcome
Timeframe: At 30 days, 12 months, and annually up to five yearsMajor Adverse Events
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
The Number of MAEs
Bleeding : 30 days
|
3 Participants
|
4 Participants
|
|
The Number of MAEs
Bleeding : 12 Months
|
3 Participants
|
4 Participants
|
|
The Number of MAEs
Bleeding : 24 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Bleeding : 36 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Bleeding : 48 Months
|
1 Participants
|
1 Participants
|
|
The Number of MAEs
Bleeding : 60 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Cardiac : 30 days
|
4 Participants
|
1 Participants
|
|
The Number of MAEs
Cardiac : 12 Months
|
5 Participants
|
12 Participants
|
|
The Number of MAEs
Cardiac : 24 Months
|
2 Participants
|
2 Participants
|
|
The Number of MAEs
Cardiac : 36 Months
|
6 Participants
|
4 Participants
|
|
The Number of MAEs
Cardiac : 48 Months
|
9 Participants
|
0 Participants
|
|
The Number of MAEs
Cardiac : 60 Months
|
4 Participants
|
2 Participants
|
|
The Number of MAEs
GI : 30 days
|
1 Participants
|
0 Participants
|
|
The Number of MAEs
GI : 12 Months
|
1 Participants
|
0 Participants
|
|
The Number of MAEs
GI : 24 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
GI : 36 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
GI : 48 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
GI : 60 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Malignancies : 30 days
|
1 Participants
|
0 Participants
|
|
The Number of MAEs
Malignancies : 12 Months
|
4 Participants
|
5 Participants
|
|
The Number of MAEs
Malignancies : 24 Months
|
5 Participants
|
3 Participants
|
|
The Number of MAEs
Malignancies : 36 Months
|
1 Participants
|
1 Participants
|
|
The Number of MAEs
Malignancies : 48 Months
|
2 Participants
|
0 Participants
|
|
The Number of MAEs
Malignancies : 60 Months
|
2 Participants
|
1 Participants
|
|
The Number of MAEs
Miscellaneous : 30 days
|
2 Participants
|
0 Participants
|
|
The Number of MAEs
Miscellaneous : 12 Months
|
5 Participants
|
2 Participants
|
|
The Number of MAEs
Miscellaneous : 24 Months
|
1 Participants
|
0 Participants
|
|
The Number of MAEs
Miscellaneous : 36 Months
|
3 Participants
|
6 Participants
|
|
The Number of MAEs
Miscellaneous : 48 Months
|
0 Participants
|
5 Participants
|
|
The Number of MAEs
Miscellaneous : 60 Months
|
3 Participants
|
1 Participants
|
|
The Number of MAEs
Neurological : 30 days
|
1 Participants
|
0 Participants
|
|
The Number of MAEs
Neurological : 12 Months
|
2 Participants
|
4 Participants
|
|
The Number of MAEs
Neurological : 24 Months
|
6 Participants
|
3 Participants
|
|
The Number of MAEs
Neurological : 36 Months
|
5 Participants
|
2 Participants
|
|
The Number of MAEs
Neurological : 48 Months
|
2 Participants
|
1 Participants
|
|
The Number of MAEs
Neurological : 60 Months
|
1 Participants
|
2 Participants
|
|
The Number of MAEs
Pulmonary : 30 days
|
1 Participants
|
0 Participants
|
|
The Number of MAEs
Pulmonary : 12 Months
|
2 Participants
|
3 Participants
|
|
The Number of MAEs
Pulmonary : 24 Months
|
5 Participants
|
2 Participants
|
|
The Number of MAEs
Pulmonary : 36 Months
|
0 Participants
|
2 Participants
|
|
The Number of MAEs
Pulmonary : 48 Months
|
2 Participants
|
3 Participants
|
|
The Number of MAEs
Pulmonary : 60 Months
|
3 Participants
|
1 Participants
|
|
The Number of MAEs
Renal : 30 days
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Renal : 12 Months
|
1 Participants
|
4 Participants
|
|
The Number of MAEs
Renal : 24 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Renal : 36 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Renal : 48 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Renal : 60 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Wound : 30 days
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Wound : 12 Months
|
0 Participants
|
1 Participants
|
|
The Number of MAEs
Wound : 24 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Wound : 36 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Wound : 48 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Wound : 60 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Vascular : 30 days
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Vascular : 12 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Vascular : 24 Months
|
0 Participants
|
0 Participants
|
|
The Number of MAEs
Vascular : 36 Months
|
1 Participants
|
0 Participants
|
|
The Number of MAEs
Vascular : 48 Months
|
2 Participants
|
0 Participants
|
|
The Number of MAEs
Vascular : 60 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post 12 Months up to Five YearsARC is a composite outcome
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
The Number of Participants With Aneurysm Related Complications (ARC)
12 Months
|
52 Participants
|
64 Participants
|
|
The Number of Participants With Aneurysm Related Complications (ARC)
24 Months
|
23 Participants
|
29 Participants
|
|
The Number of Participants With Aneurysm Related Complications (ARC)
36 Months
|
22 Participants
|
22 Participants
|
|
The Number of Participants With Aneurysm Related Complications (ARC)
48 Months
|
23 Participants
|
16 Participants
|
|
The Number of Participants With Aneurysm Related Complications (ARC)
60 Months
|
19 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to Five YearsDeath related to the aneurysm
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
The Number of Participants With Aneurysm Related Mortality
3 Years
|
1 Participants
|
1 Participants
|
|
The Number of Participants With Aneurysm Related Mortality
1 Year
|
3 Participants
|
1 Participants
|
|
The Number of Participants With Aneurysm Related Mortality
2 Years
|
0 Participants
|
1 Participants
|
|
The Number of Participants With Aneurysm Related Mortality
4 Years
|
2 Participants
|
1 Participants
|
|
The Number of Participants With Aneurysm Related Mortality
5 Years
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Five YearsNumber of participants with Type Ia endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ia endoleak defined as persistent leak around the top of the stent graft identified during imaging surveillance at the different timepoints.
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Number of Type Ia Endoleaks
12 Months
|
2 Participants
|
0 Participants
|
|
Number of Type Ia Endoleaks
24 Months
|
0 Participants
|
0 Participants
|
|
Number of Type Ia Endoleaks
36 Months
|
0 Participants
|
1 Participants
|
|
Number of Type Ia Endoleaks
48 Months
|
3 Participants
|
1 Participants
|
|
Number of Type Ia Endoleaks
60 Months
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Five YearsNumber of participants with Type Ib endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ib endoleak defined as persistent leak around the bottom of the stent graft identified during imaging surveillance at the different timepoints.
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Number of Type Ib Endoleaks
12 Months
|
4 Participants
|
3 Participants
|
|
Number of Type Ib Endoleaks
24 Months
|
0 Participants
|
0 Participants
|
|
Number of Type Ib Endoleaks
36 Months
|
0 Participants
|
0 Participants
|
|
Number of Type Ib Endoleaks
48 Months
|
0 Participants
|
0 Participants
|
|
Number of Type Ib Endoleaks
60 Months
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Five YearsNumber of participants with Type II endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type II endoleak defined as persistent blood flow into the aneurysm sac from branches of the aorta identified during imaging surveillance at the different timepoints.
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Number Endoleaks Type II
12 Months
|
36 Participants
|
48 Participants
|
|
Number Endoleaks Type II
24 Months
|
5 Participants
|
3 Participants
|
|
Number Endoleaks Type II
36 Months
|
2 Participants
|
4 Participants
|
|
Number Endoleaks Type II
48 Months
|
1 Participants
|
0 Participants
|
|
Number Endoleaks Type II
60 Months
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Five YearsNumber of participants with Type IIIa endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIa endoleak defined as persistent leak from the overlapping parts of the stent graft identified during imaging surveillance at the different timepoints.
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Number of Endoleaks Type IIIa
12 Months
|
0 Participants
|
0 Participants
|
|
Number of Endoleaks Type IIIa
24 Months
|
0 Participants
|
0 Participants
|
|
Number of Endoleaks Type IIIa
36 Months
|
0 Participants
|
0 Participants
|
|
Number of Endoleaks Type IIIa
48 Months
|
0 Participants
|
0 Participants
|
|
Number of Endoleaks Type IIIa
60 Months
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Five YearsNumber of participants with Type IIIb endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIb endoleak defined as persistent leak as a consequence of graft rupture, identified during imaging surveillance at the different timepoints.
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Number of Endoleaks Type IIIb
12 Months
|
0 Participants
|
0 Participants
|
|
Number of Endoleaks Type IIIb
24 Months
|
0 Participants
|
0 Participants
|
|
Number of Endoleaks Type IIIb
36 Months
|
1 Participants
|
0 Participants
|
|
Number of Endoleaks Type IIIb
48 Months
|
0 Participants
|
0 Participants
|
|
Number of Endoleaks Type IIIb
60 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 Months, 24 Months, 36 Months, 48 Months, 60 MonthsNumber of Participants with Aneurysm Rupture at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Number of Participants With Aneurysm Rupture
12 Months
|
0 Participants
|
0 Participants
|
|
Number of Participants With Aneurysm Rupture
24 Months
|
0 Participants
|
0 Participants
|
|
Number of Participants With Aneurysm Rupture
36 Months
|
1 Participants
|
0 Participants
|
|
Number of Participants With Aneurysm Rupture
48 Months
|
1 Participants
|
1 Participants
|
|
Number of Participants With Aneurysm Rupture
60 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 Months, 24 Months, 36 Months, 48 Months, 60 MonthsNumber of Participants that underwent an Open Conversions at 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Number of Participants With Open Conversion
12 Months
|
0 Participants
|
3 Participants
|
|
Number of Participants With Open Conversion
24 Months
|
0 Participants
|
1 Participants
|
|
Number of Participants With Open Conversion
36 Months
|
0 Participants
|
0 Participants
|
|
Number of Participants With Open Conversion
48 Months
|
0 Participants
|
0 Participants
|
|
Number of Participants With Open Conversion
60 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 Months, 24 Months, 36 Months, 48 Months, 60 MonthsNumber of Participants with Aneurysm Expansion at 12 Months, 24 Months, 36 Months, 48 months, 60 Months
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Number of Participants With Aneurysm Expansion
12 Months
|
2 Participants
|
4 Participants
|
|
Number of Participants With Aneurysm Expansion
24 Months
|
4 Participants
|
1 Participants
|
|
Number of Participants With Aneurysm Expansion
36 Months
|
2 Participants
|
3 Participants
|
|
Number of Participants With Aneurysm Expansion
48 Months
|
9 Participants
|
4 Participants
|
|
Number of Participants With Aneurysm Expansion
60 Months
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 Months, 24 Months, 36 Months, 48 Months and 60 MonthsNumber of Patients with Endograft Occlusion at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Number of Patients With Endograft Occlusion
12 Months
|
3 Participants
|
8 Participants
|
|
Number of Patients With Endograft Occlusion
24 Months
|
0 Participants
|
1 Participants
|
|
Number of Patients With Endograft Occlusion
36 Months
|
0 Participants
|
1 Participants
|
|
Number of Patients With Endograft Occlusion
48 Months
|
1 Participants
|
1 Participants
|
|
Number of Patients With Endograft Occlusion
60 Months
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 MonthsNumber of Participants with Device-Related Secondary Interventions at 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Number of Participants With Device-Related Secondary Interventions
30 Days
|
5 Participants
|
2 Participants
|
|
Number of Participants With Device-Related Secondary Interventions
12 Months
|
11 Participants
|
12 Participants
|
|
Number of Participants With Device-Related Secondary Interventions
24 Months
|
3 Participants
|
3 Participants
|
|
Number of Participants With Device-Related Secondary Interventions
36 Months
|
7 Participants
|
4 Participants
|
|
Number of Participants With Device-Related Secondary Interventions
48 Months
|
5 Participants
|
6 Participants
|
|
Number of Participants With Device-Related Secondary Interventions
60 Months
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralNumber of patients with adjunctive procedure during the implant
Outcome measures
| Measure |
AFX EVAR AAA Graft System
n=235 Participants
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 Participants
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Number of Patients With Adjunctive Procedures
|
3 Participants
|
1 Participants
|
Adverse Events
AFX EVAR AAA Graft System
Serious events: 150 serious events
Other events: 167 other events
Deaths: 64 deaths
FDA Approved EVAR AAA Graft Systems
Serious events: 136 serious events
Other events: 162 other events
Deaths: 50 deaths
Serious adverse events
| Measure |
AFX EVAR AAA Graft System
n=235 participants at risk；n=376 participants at risk
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 participants at risk；n=358 participants at risk
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Vascular disorders
Aneurysm Rupture
|
0.00%
0/376 • AEs are collected through 5 year follow-up visit.
|
0.00%
0/358 • AEs are collected through 5 year follow-up visit.
|
|
Cardiac disorders
cardiac
|
13.8%
52/376 • Number of events 68 • AEs are collected through 5 year follow-up visit.
|
10.6%
38/358 • Number of events 62 • AEs are collected through 5 year follow-up visit.
|
|
Blood and lymphatic system disorders
Bleeding
|
4.0%
15/376 • Number of events 17 • AEs are collected through 5 year follow-up visit.
|
5.0%
18/358 • Number of events 21 • AEs are collected through 5 year follow-up visit.
|
|
Vascular disorders
Device
|
7.4%
28/376 • Number of events 34 • AEs are collected through 5 year follow-up visit.
|
6.1%
22/358 • Number of events 28 • AEs are collected through 5 year follow-up visit.
|
|
Gastrointestinal disorders
GI
|
3.7%
14/376 • Number of events 15 • AEs are collected through 5 year follow-up visit.
|
3.9%
14/358 • Number of events 17 • AEs are collected through 5 year follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignancies
|
8.2%
31/376 • Number of events 33 • AEs are collected through 5 year follow-up visit.
|
5.6%
20/358 • Number of events 21 • AEs are collected through 5 year follow-up visit.
|
|
Nervous system disorders
neurological
|
5.3%
20/376 • Number of events 29 • AEs are collected through 5 year follow-up visit.
|
5.9%
21/358 • Number of events 21 • AEs are collected through 5 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary
|
9.8%
37/376 • Number of events 53 • AEs are collected through 5 year follow-up visit.
|
7.8%
28/358 • Number of events 46 • AEs are collected through 5 year follow-up visit.
|
|
Renal and urinary disorders
Renal
|
3.5%
13/376 • Number of events 13 • AEs are collected through 5 year follow-up visit.
|
5.3%
19/358 • Number of events 20 • AEs are collected through 5 year follow-up visit.
|
|
Vascular disorders
Vascular
|
6.9%
26/376 • Number of events 35 • AEs are collected through 5 year follow-up visit.
|
8.9%
32/358 • Number of events 40 • AEs are collected through 5 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Wound
|
1.1%
4/376 • Number of events 4 • AEs are collected through 5 year follow-up visit.
|
1.7%
6/358 • Number of events 8 • AEs are collected through 5 year follow-up visit.
|
|
General disorders
Miscellaneous
|
11.7%
44/376 • Number of events 61 • AEs are collected through 5 year follow-up visit.
|
15.1%
54/358 • Number of events 66 • AEs are collected through 5 year follow-up visit.
|
Other adverse events
| Measure |
AFX EVAR AAA Graft System
n=235 participants at risk；n=376 participants at risk
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
FDA Approved EVAR AAA Graft Systems
n=220 participants at risk；n=358 participants at risk
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
8.9%
21/235 • Number of events 23 • AEs are collected through 5 year follow-up visit.
|
8.6%
19/220 • Number of events 22 • AEs are collected through 5 year follow-up visit.
|
|
Cardiac disorders
Cardiac
|
22.1%
52/235 • Number of events 68 • AEs are collected through 5 year follow-up visit.
|
17.3%
38/220 • Number of events 62 • AEs are collected through 5 year follow-up visit.
|
|
Vascular disorders
Device
|
26.0%
61/235 • Number of events 67 • AEs are collected through 5 year follow-up visit.
|
28.6%
63/220 • Number of events 72 • AEs are collected through 5 year follow-up visit.
|
|
Gastrointestinal disorders
GI
|
6.0%
14/235 • Number of events 15 • AEs are collected through 5 year follow-up visit.
|
6.4%
14/220 • Number of events 17 • AEs are collected through 5 year follow-up visit.
|
|
General disorders
miscellaneous
|
19.6%
46/235 • Number of events 63 • AEs are collected through 5 year follow-up visit.
|
25.5%
56/220 • Number of events 68 • AEs are collected through 5 year follow-up visit.
|
|
Nervous system disorders
Neurological
|
9.4%
22/235 • Number of events 32 • AEs are collected through 5 year follow-up visit.
|
10.0%
22/220 • Number of events 22 • AEs are collected through 5 year follow-up visit.
|
|
Renal and urinary disorders
Renal
|
6.8%
16/235 • Number of events 18 • AEs are collected through 5 year follow-up visit.
|
10.0%
22/220 • Number of events 23 • AEs are collected through 5 year follow-up visit.
|
|
Vascular disorders
vascular
|
16.6%
39/235 • Number of events 51 • AEs are collected through 5 year follow-up visit.
|
20.0%
44/220 • Number of events 58 • AEs are collected through 5 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
wound
|
1.7%
4/235 • Number of events 4 • AEs are collected through 5 year follow-up visit.
|
3.2%
7/220 • Number of events 9 • AEs are collected through 5 year follow-up visit.
|
|
Renal and urinary disorders
Urogenital
|
5.1%
12/235 • Number of events 14 • AEs are collected through 5 year follow-up visit.
|
4.1%
9/220 • Number of events 9 • AEs are collected through 5 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
15.7%
37/235 • Number of events 53 • AEs are collected through 5 year follow-up visit.
|
12.7%
28/220 • Number of events 46 • AEs are collected through 5 year follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignancies
|
13.2%
31/235 • Number of events 33 • AEs are collected through 5 year follow-up visit.
|
9.1%
20/220 • Number of events 21 • AEs are collected through 5 year follow-up visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall be free to publish Institution's data/results from the Clinical Study at time of multicenter results published, notification that publication is not planned, or 18 months after the study conclusion at all centers, whichever occurs first.
- Publication restrictions are in place
Restriction type: OTHER