N/A
Completed N=455
Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
Source: ClinicalTrials.gov NCT02407457 ↗Enrolled (actual)
455
Serious AEs
39.0%
Results posted
Sep 2020
Primary outcomePrimary: Number of Patients With Absence of Aneurysm Related Complications (ARC) — 195; 175 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Absence of Aneurysm Related Complications (ARC) |
195; 175 | — |
| SECONDARY The Number of MAEs |
3; 4; 3; 4; 0; 0 | — |
| SECONDARY The Number of Participants With Aneurysm Related Complications (ARC) |
52; 64; 23; 29; 22; 22 | — |
| SECONDARY The Number of Participants With Aneurysm Related Mortality |
3; 1; 0; 1; 1; 1 | — |
| SECONDARY Number of Type Ia Endoleaks |
2; 0; 0; 0; 0; 1 | — |
| SECONDARY Number of Type Ib Endoleaks |
4; 3; 0; 0; 0; 0 | — |
| SECONDARY Number Endoleaks Type II |
36; 48; 5; 3; 2; 4 | — |
| SECONDARY Number of Endoleaks Type IIIa |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Endoleaks Type IIIb |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Aneurysm Rupture |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Open Conversion |
0; 3; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Aneurysm Expansion |
2; 4; 4; 1; 2; 3 | — |
| SECONDARY Number of Patients With Endograft Occlusion |
3; 8; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Device-Related Secondary Interventions |
5; 2; 11; 12; 3; 3 | — |
| SECONDARY Number of Patients With Adjunctive Procedures |
3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female at least 18 years old
- Subjects with minimum of 2 year life expectancy
- Subjects have signed the informed consent document for data release
- 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
- Currently participating in another study where primary endpoint has not been reached yet
- Known allergy to any of the device components
- Pregnant (females of childbearing potential only)
- Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR
Data sourced from ClinicalTrials.gov (NCT02407457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.