Trials / Recruiting
RecruitingNCT04503395
ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- Sponsor
- FCRE (Foundation for Cardiovascular Research and Education) · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ESAR treatment: Endograft + Heli-FX Endoanchor | ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor |
| DEVICE | FEVAR treatment : Fenestrated endograft | Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft |
Timeline
- Start date
- 2021-05-21
- Primary completion
- 2026-06-01
- Completion
- 2028-06-01
- First posted
- 2020-08-07
- Last updated
- 2025-04-30
Locations
32 sites across 10 countries: United States, Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04503395. Inclusion in this directory is not an endorsement.