Long-term assessment of the AFX2 System for abdominal aortic aneurysm repair
The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System
This study looks at how well the AFX2 System works for repairing abdominal aortic aneurysms over five years compared to other devices, focusing on the risk of a specific complication called Type III endoleaks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Endologix Industry-sponsored |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT06990048 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the long-term performance of the AFX2 System in patients who have undergone endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms. It utilizes real-world evidence from the Vascular Quality Initiative (VQI) to compare outcomes of the AFX2 System with other commonly used EVAR devices. The study specifically focuses on the occurrence of Type III endoleaks in patients over a five-year period.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have been implanted with the AFX2 System or one of the three most commonly used comparator devices for their first abdominal aortic aneurysm repair.
Not a fit: Patients who underwent ruptured AAA repair or those with relined grafts will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of the AFX2 System, potentially improving treatment options for patients with abdominal aortic aneurysms.
How similar studies have performed: Other studies evaluating the performance of EVAR devices have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients implanted with the AFX2 System or the 3 most commonly used comparator devices who underwent EVAR as their first abdominal aortic aneurysm repair in the VQI EVAR registry will be included in this study. Exclusion Criteria: * Ruptured AAA repair with the AFX2 or comparator device * Patients with AFX2 in AFX relining, or relined comparator grafts.
Where this trial is running
Lebanon, New Hampshire
- The Dartmouth Institute — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Study coordinator: Tammy Stiver
- Email: tstiver@endologix.com
- Phone: 1-513-673-1452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.