Trials / Recruiting
RecruitingNCT06990048
The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (estimated)
- Sponsor
- Endologix · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION.
Detailed description
Evaluate the clinical performance of the AFX2 System patients against other commercially available EVAR devices and evaluate the Type III endoleak occurrence in AFX2 System patients through 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AFX2 System | The AFX2 System comprises of the following: AFX2 Bifurcated Endograft System and delivery system AFX Vela Proxmal Endograft System and delivery system AFX Stand Alone Endograft System and delivery system |
Timeline
- Start date
- 2023-09-21
- Primary completion
- 2027-05-01
- Completion
- 2027-05-01
- First posted
- 2025-05-25
- Last updated
- 2025-05-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06990048. Inclusion in this directory is not an endorsement.