Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck
FCRE (Foundation for Cardiovascular Research and Education)
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject is \>18 years old * Subject is scheduled for primary treatment of the abdominal aortic aneurysm with a non-aneurysmal infrarenal aortic sealing zone proximal to the aneurysm that is sufficiently healthy for a proximal neck length that is at least 4mm and not more than15 mm and has a circumferential minimum sealing zone length of 8 mm * Subject is not a candidate for safe, effective and durable standard EVAR due to challenging anatomical criteria as confirmed by the Core Lab screening * Subject is able and willing to comply with the protocol and to adhere to the f…
Interventions
- DeviceESAR treatment: Endograft + Heli-FX Endoanchor
ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor
- DeviceFEVAR treatment : Fenestrated endograft
Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft
Locations (32)
- UCSD Medical Center HillcrestLa Jolla, California
- Stanford UniversityStanford, California
- University of FloridaGainesville, Florida
- Corewell Health (Spectrum)Grand Rapids, Michigan
- Mount Sinai HospitalNew York, New York
- Atrium Health Carolinas Medical CenterCharlotte, North Carolina