Abdominal Aortic Aneurysm
Conditions
Brief summary
The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S clinical centers will be involved in the trial to include a broad range of experience. Imaging data will be evaluated by an independent core lab.
Detailed description
This trial is a prospective, randomized, multi-center trial, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The trial is designed to compare the anatomically stabilized AFX Endograft System to a reference group of proximally fixated EVAR devices. Patients will be randomized between the two groups. Randomization will be 1:1. Each investigator will select one comparator device of their choice before enrolling the first patient. The study will sequentially evaluate non-inferiority and superiority hypotheses. Up to 80 sites with experience in EVAR and up to 800 subjects will participate in this study.
Interventions
DEVICEAFX EVAR AAA Graft System
Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
Sponsors
Endologix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female at least 18 years old 2. Subjects with minimum of 2 year life expectancy 3. Subjects have signed the informed consent document for data release 4. Subjects with infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.
Exclusion criteria
1. Currently participating in another study where primary endpoint has not been reached yet 2. Known allergy to any of the device components 3. Pregnant (females of childbearing potential only) 4. Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Absence of Aneurysm Related Complications (ARC) | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Aneurysm Related Complications (ARC) | Post 12 Months up to Five Years | ARC is a composite outcome |
| The Number of Participants With Aneurysm Related Mortality | Up to Five Years | Death related to the aneurysm |
| Number of Type Ia Endoleaks | Up to Five Years | Number 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. |
| Number of Type Ib Endoleaks | Up to Five Years | Number 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. |
| Number Endoleaks Type II | Up to Five Years | Number 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. |
| Number of Endoleaks Type IIIa | Up to Five Years | Number 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. |
| The Number of MAEs | At 30 days, 12 months, and annually up to five years | Major Adverse Events |
| Number of Participants With Aneurysm Rupture | 12 Months, 24 Months, 36 Months, 48 Months, 60 Months | Number of Participants with Aneurysm Rupture at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months |
| Number of Participants With Open Conversion | 12 Months, 24 Months, 36 Months, 48 Months, 60 Months | Number of Participants that underwent an Open Conversions at 12 Months, 24 Months, 36 Months, 48 Months, 60 Months |
| Number of Participants With Aneurysm Expansion | 12 Months, 24 Months, 36 Months, 48 Months, 60 Months | Number of Participants with Aneurysm Expansion at 12 Months, 24 Months, 36 Months, 48 months, 60 Months |
| Number of Patients With Endograft Occlusion | 12 Months, 24 Months, 36 Months, 48 Months and 60 Months | Number of Patients with Endograft Occlusion at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months |
| Number of Participants With Device-Related Secondary Interventions | 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months | Number of Participants with Device-Related Secondary Interventions at 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months |
| Number of Patients With Adjunctive Procedures | Intraprocedural | Number of patients with adjunctive procedure during the implant |
| Number of Endoleaks Type IIIb | Up to Five Years | Number 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 235 |
| 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 | 220 |
| Total | 455 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1 Month | Death | 3 | 0 |
| 1 Month | Lost to Follow-up | 1 | 1 |
| 1 Month | missed visit | 2 | 5 |
| 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 |
| 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 |
Baseline characteristics
| Characteristic | FDA Approved EVAR AAA Graft Systems | Total | AFX EVAR AAA Graft System |
|---|---|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 8 | 72 years STANDARD_DEVIATION 8 | 72 years STANDARD_DEVIATION 8 |
| ASA Classification ASA Class 1/2 | 62 Participants | 133 Participants | 71 Participants |
| ASA Classification ASA Class 3/4/5 | 158 Participants | 322 Participants | 164 Participants |
| Race/Ethnicity, Customized Caucasian | 199 Participants | 424 Participants | 225 Participants |
| Race/Ethnicity, Customized Non-caucasian | 21 Participants | 31 Participants | 10 Participants |
| Sex: Female, Male Female | 28 Participants | 51 Participants | 23 Participants |
| Sex: Female, Male Male | 192 Participants | 404 Participants | 212 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 64 / 235 | 50 / 220 |
| other Total, other adverse events | 167 / 235 | 162 / 220 |
| serious Total, serious adverse events | 150 / 376 | 136 / 358 |
Outcome results
Primary
Number of Patients With Absence of Aneurysm Related Complications (ARC)
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
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AFX EVAR AAA Graft System | Number of Patients With Absence of Aneurysm Related Complications (ARC) | 195 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Patients With Absence of Aneurysm Related Complications (ARC) | 175 Participants |
Secondary
Number Endoleaks Type II
Number 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.
Time frame: Up to Five Years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AFX EVAR AAA Graft System | Number Endoleaks Type II | 24 Months | 5 Participants |
| AFX EVAR AAA Graft System | Number Endoleaks Type II | 48 Months | 1 Participants |
| AFX EVAR AAA Graft System | Number Endoleaks Type II | 36 Months | 2 Participants |
| AFX EVAR AAA Graft System | Number Endoleaks Type II | 60 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number Endoleaks Type II | 12 Months | 36 Participants |
| FDA Approved EVAR AAA Graft Systems | Number Endoleaks Type II | 60 Months | 3 Participants |
| FDA Approved EVAR AAA Graft Systems | Number Endoleaks Type II | 12 Months | 48 Participants |
| FDA Approved EVAR AAA Graft Systems | Number Endoleaks Type II | 24 Months | 3 Participants |
| FDA Approved EVAR AAA Graft Systems | Number Endoleaks Type II | 36 Months | 4 Participants |
| FDA Approved EVAR AAA Graft Systems | Number Endoleaks Type II | 48 Months | 0 Participants |
Secondary
Number of Endoleaks Type IIIa
Number 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.
Time frame: Up to Five Years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AFX EVAR AAA Graft System | Number of Endoleaks Type IIIa | 24 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Endoleaks Type IIIa | 48 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Endoleaks Type IIIa | 36 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Endoleaks Type IIIa | 60 Months | 1 Participants |
| AFX EVAR AAA Graft System | Number of Endoleaks Type IIIa | 12 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Endoleaks Type IIIa | 60 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Endoleaks Type IIIa | 12 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Endoleaks Type IIIa | 24 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Endoleaks Type IIIa | 36 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Endoleaks Type IIIa | 48 Months | 0 Participants |
Secondary
Number of Endoleaks Type IIIb
Number 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.
Time frame: Up to Five Years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AFX EVAR AAA Graft System | Number of Endoleaks Type IIIb | 24 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Endoleaks Type IIIb | 48 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Endoleaks Type IIIb | 36 Months | 1 Participants |
| AFX EVAR AAA Graft System | Number of Endoleaks Type IIIb | 60 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Endoleaks Type IIIb | 12 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Endoleaks Type IIIb | 60 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Endoleaks Type IIIb | 12 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Endoleaks Type IIIb | 24 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Endoleaks Type IIIb | 36 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Endoleaks Type IIIb | 48 Months | 0 Participants |
Secondary
Number of Participants With Aneurysm Expansion
Number of Participants with Aneurysm Expansion at 12 Months, 24 Months, 36 Months, 48 months, 60 Months
Time frame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AFX EVAR AAA Graft System | Number of Participants With Aneurysm Expansion | 24 Months | 4 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Aneurysm Expansion | 48 Months | 9 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Aneurysm Expansion | 36 Months | 2 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Aneurysm Expansion | 60 Months | 7 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Aneurysm Expansion | 12 Months | 2 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Aneurysm Expansion | 60 Months | 5 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Aneurysm Expansion | 12 Months | 4 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Aneurysm Expansion | 24 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Aneurysm Expansion | 36 Months | 3 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Aneurysm Expansion | 48 Months | 4 Participants |
Secondary
Number of Participants With Aneurysm Rupture
Number of Participants with Aneurysm Rupture at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
Time frame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AFX EVAR AAA Graft System | Number of Participants With Aneurysm Rupture | 24 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Aneurysm Rupture | 48 Months | 1 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Aneurysm Rupture | 36 Months | 1 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Aneurysm Rupture | 60 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Aneurysm Rupture | 12 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Aneurysm Rupture | 60 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Aneurysm Rupture | 12 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Aneurysm Rupture | 24 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Aneurysm Rupture | 36 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Aneurysm Rupture | 48 Months | 1 Participants |
Secondary
Number of Participants With Device-Related Secondary Interventions
Number of Participants with Device-Related Secondary Interventions at 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Time frame: 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AFX EVAR AAA Graft System | Number of Participants With Device-Related Secondary Interventions | 30 Days | 5 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Device-Related Secondary Interventions | 12 Months | 11 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Device-Related Secondary Interventions | 24 Months | 3 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Device-Related Secondary Interventions | 36 Months | 7 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Device-Related Secondary Interventions | 48 Months | 5 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Device-Related Secondary Interventions | 60 Months | 5 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Device-Related Secondary Interventions | 48 Months | 6 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Device-Related Secondary Interventions | 30 Days | 2 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Device-Related Secondary Interventions | 36 Months | 4 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Device-Related Secondary Interventions | 12 Months | 12 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Device-Related Secondary Interventions | 60 Months | 5 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Device-Related Secondary Interventions | 24 Months | 3 Participants |
Secondary
Number of Participants With Open Conversion
Number of Participants that underwent an Open Conversions at 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Time frame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AFX EVAR AAA Graft System | Number of Participants With Open Conversion | 24 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Open Conversion | 48 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Open Conversion | 36 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Open Conversion | 60 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Participants With Open Conversion | 12 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Open Conversion | 60 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Open Conversion | 12 Months | 3 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Open Conversion | 24 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Open Conversion | 36 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Participants With Open Conversion | 48 Months | 0 Participants |
Secondary
Number of Patients With Adjunctive Procedures
Number of patients with adjunctive procedure during the implant
Time frame: Intraprocedural
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AFX EVAR AAA Graft System | Number of Patients With Adjunctive Procedures | 3 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Patients With Adjunctive Procedures | 1 Participants |
Secondary
Number of Patients With Endograft Occlusion
Number of Patients with Endograft Occlusion at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
Time frame: 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AFX EVAR AAA Graft System | Number of Patients With Endograft Occlusion | 36 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Patients With Endograft Occlusion | 48 Months | 1 Participants |
| AFX EVAR AAA Graft System | Number of Patients With Endograft Occlusion | 24 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Patients With Endograft Occlusion | 60 Months | 1 Participants |
| AFX EVAR AAA Graft System | Number of Patients With Endograft Occlusion | 12 Months | 3 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Patients With Endograft Occlusion | 60 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Patients With Endograft Occlusion | 12 Months | 8 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Patients With Endograft Occlusion | 24 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Patients With Endograft Occlusion | 48 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Patients With Endograft Occlusion | 36 Months | 1 Participants |
Secondary
Number of Type Ia Endoleaks
Number 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.
Time frame: Up to Five Years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AFX EVAR AAA Graft System | Number of Type Ia Endoleaks | 24 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Type Ia Endoleaks | 48 Months | 3 Participants |
| AFX EVAR AAA Graft System | Number of Type Ia Endoleaks | 36 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Type Ia Endoleaks | 60 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Type Ia Endoleaks | 12 Months | 2 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Type Ia Endoleaks | 60 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Type Ia Endoleaks | 12 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Type Ia Endoleaks | 24 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Type Ia Endoleaks | 36 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Type Ia Endoleaks | 48 Months | 1 Participants |
Secondary
Number of Type Ib Endoleaks
Number 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.
Time frame: Up to Five Years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AFX EVAR AAA Graft System | Number of Type Ib Endoleaks | 24 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Type Ib Endoleaks | 48 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Type Ib Endoleaks | 36 Months | 0 Participants |
| AFX EVAR AAA Graft System | Number of Type Ib Endoleaks | 60 Months | 1 Participants |
| AFX EVAR AAA Graft System | Number of Type Ib Endoleaks | 12 Months | 4 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Type Ib Endoleaks | 60 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Type Ib Endoleaks | 12 Months | 3 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Type Ib Endoleaks | 24 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Type Ib Endoleaks | 36 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | Number of Type Ib Endoleaks | 48 Months | 0 Participants |
Secondary
The Number of MAEs
Major Adverse Events
Time frame: At 30 days, 12 months, and annually up to five years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AFX EVAR AAA Graft System | The Number of MAEs | Renal : 24 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | GI : 48 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Bleeding : 30 days | 3 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Bleeding : 12 Months | 3 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Bleeding : 24 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Bleeding : 36 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Bleeding : 48 Months | 1 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Bleeding : 60 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Cardiac : 30 days | 4 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Cardiac : 12 Months | 5 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Cardiac : 24 Months | 2 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Cardiac : 36 Months | 6 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Cardiac : 48 Months | 9 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Cardiac : 60 Months | 4 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | GI : 30 days | 1 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | GI : 12 Months | 1 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | GI : 24 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | GI : 36 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | GI : 60 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Malignancies : 30 days | 1 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Malignancies : 12 Months | 4 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Malignancies : 24 Months | 5 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Malignancies : 36 Months | 1 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Malignancies : 48 Months | 2 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Malignancies : 60 Months | 2 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Miscellaneous : 30 days | 2 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Miscellaneous : 12 Months | 5 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Miscellaneous : 24 Months | 1 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Miscellaneous : 36 Months | 3 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Miscellaneous : 48 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Miscellaneous : 60 Months | 3 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Neurological : 30 days | 1 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Neurological : 12 Months | 2 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Neurological : 24 Months | 6 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Neurological : 36 Months | 5 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Neurological : 48 Months | 2 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Neurological : 60 Months | 1 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Pulmonary : 30 days | 1 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Pulmonary : 12 Months | 2 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Pulmonary : 24 Months | 5 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Pulmonary : 36 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Pulmonary : 48 Months | 2 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Pulmonary : 60 Months | 3 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Renal : 30 days | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Renal : 12 Months | 1 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Renal : 36 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Renal : 48 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Renal : 60 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Wound : 30 days | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Wound : 12 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Wound : 24 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Wound : 36 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Wound : 48 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Wound : 60 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Vascular : 30 days | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Vascular : 12 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Vascular : 24 Months | 0 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Vascular : 36 Months | 1 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Vascular : 48 Months | 2 Participants |
| AFX EVAR AAA Graft System | The Number of MAEs | Vascular : 60 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Miscellaneous : 60 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Vascular : 12 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Neurological : 30 days | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Bleeding : 30 days | 4 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Renal : 36 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Bleeding : 12 Months | 4 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Neurological : 12 Months | 4 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Bleeding : 24 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Wound : 48 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Bleeding : 36 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Neurological : 24 Months | 3 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Bleeding : 48 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Renal : 48 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Bleeding : 60 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Neurological : 36 Months | 2 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Cardiac : 30 days | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Vascular : 36 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Cardiac : 12 Months | 12 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Neurological : 48 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Cardiac : 24 Months | 2 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Renal : 60 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Cardiac : 36 Months | 4 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Neurological : 60 Months | 2 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Cardiac : 48 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Wound : 60 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Cardiac : 60 Months | 2 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Pulmonary : 30 days | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | GI : 30 days | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Wound : 30 days | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | GI : 12 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Pulmonary : 12 Months | 3 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | GI : 24 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Vascular : 24 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | GI : 36 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | GI : 48 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Pulmonary : 24 Months | 2 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | GI : 60 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Wound : 12 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Malignancies : 30 days | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Pulmonary : 36 Months | 2 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Malignancies : 12 Months | 5 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Vascular : 30 days | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Malignancies : 24 Months | 3 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Pulmonary : 48 Months | 3 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Malignancies : 36 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Wound : 24 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Malignancies : 48 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Pulmonary : 60 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Malignancies : 60 Months | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Vascular : 48 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Miscellaneous : 30 days | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Renal : 30 days | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Miscellaneous : 12 Months | 2 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Wound : 36 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Miscellaneous : 24 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Renal : 12 Months | 4 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Miscellaneous : 36 Months | 6 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Vascular : 60 Months | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Miscellaneous : 48 Months | 5 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of MAEs | Renal : 24 Months | 0 Participants |
Secondary
The Number of Participants With Aneurysm Related Complications (ARC)
ARC is a composite outcome
Time frame: Post 12 Months up to Five Years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AFX EVAR AAA Graft System | The Number of Participants With Aneurysm Related Complications (ARC) | 24 Months | 23 Participants |
| AFX EVAR AAA Graft System | The Number of Participants With Aneurysm Related Complications (ARC) | 48 Months | 23 Participants |
| AFX EVAR AAA Graft System | The Number of Participants With Aneurysm Related Complications (ARC) | 36 Months | 22 Participants |
| AFX EVAR AAA Graft System | The Number of Participants With Aneurysm Related Complications (ARC) | 60 Months | 19 Participants |
| AFX EVAR AAA Graft System | The Number of Participants With Aneurysm Related Complications (ARC) | 12 Months | 52 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of Participants With Aneurysm Related Complications (ARC) | 60 Months | 16 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of Participants With Aneurysm Related Complications (ARC) | 12 Months | 64 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of Participants With Aneurysm Related Complications (ARC) | 24 Months | 29 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of Participants With Aneurysm Related Complications (ARC) | 36 Months | 22 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of Participants With Aneurysm Related Complications (ARC) | 48 Months | 16 Participants |
Secondary
The Number of Participants With Aneurysm Related Mortality
Death related to the aneurysm
Time frame: Up to Five Years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AFX EVAR AAA Graft System | The Number of Participants With Aneurysm Related Mortality | 2 Years | 0 Participants |
| AFX EVAR AAA Graft System | The Number of Participants With Aneurysm Related Mortality | 4 Years | 2 Participants |
| AFX EVAR AAA Graft System | The Number of Participants With Aneurysm Related Mortality | 3 Years | 1 Participants |
| AFX EVAR AAA Graft System | The Number of Participants With Aneurysm Related Mortality | 5 Years | 0 Participants |
| AFX EVAR AAA Graft System | The Number of Participants With Aneurysm Related Mortality | 1 Year | 3 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of Participants With Aneurysm Related Mortality | 5 Years | 0 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of Participants With Aneurysm Related Mortality | 1 Year | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of Participants With Aneurysm Related Mortality | 2 Years | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of Participants With Aneurysm Related Mortality | 3 Years | 1 Participants |
| FDA Approved EVAR AAA Graft Systems | The Number of Participants With Aneurysm Related Mortality | 4 Years | 1 Participants |