Recruiting

ESAR & FEVARShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Sponsor:

FCRE (Foundation for Cardiovascular Research and Education)

Code:

NCT04503395

Conditions

Aortic Aneurysm, Abdominal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ESAR treatment: Endograft + Heli-FX Endoanchor

FEVAR treatment : Fenestrated endograft

Study Details

Brief 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

Aortic Aneurysm, Abdominal

Study ID

NCT04503395

Start date

May 21, 2021

Status verified date

May, 2026

Completion date

Jun 1, 2032

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 follow-up requirements.
Subject has provided written informed consent

CT Angiographic Inclusion Criteria

Subject meets the other anatomical requirements according to the locally applicable Endurant II/IIs stent graft system, Heli-FX EndoAnchor system, Terumo Fenestrated Anaconda (available in EU only) and/or Cook Zenith Fenestrated Graft Instructions for Use
Proximal neck length of the aorta within 4-15mm and a minimum circumferential sealing zone of 8mm
Aortic neck diameter from 19 to 31mm
Infrarenal neck angulation ≤45°

Exclusion Criteria:

Subject is participating in a concurrent study which may confound study results
Subject has a life expectancy <2 year
Subject is female of childbearing potential in whom pregnancy cannot be excluded
Subject with eGFR <30 mL/min/m2 (KDOQI classification - exclude class IV and above) and or on dialysis
Subject with a MI or CVA within 3 months prior to index procedure
Subject with known Connective Tissue Disease
Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to post-treatment
Subject who has undergone prior endovascular or open surgical treatment for abdominal aortic aneurysm
Subject requires emergent aneurysm treatment, for example, trauma or rupture
Subject has a known hypersensitivity or allergies to study device implant material
Subject has an aneurysm that is:

Suprarenal, pararenal, or thoracoabdominal
Mycotic
Inflammatory
Pseudoaneurysm
Subject is presenting with thrombus or calcification of the proximal aneurysm neck: circumferential >50%
Pre-op stenosis of the renal arteries > 50%
Subject has active infection or history of COVID-19. History of COVID-19 is defined as availability of positive COVID-19 test with sequelae or hospitalization for treatment of COVID-19.

Study Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ESAR

Endovascular Aneurysm Repair + Heli-FX EndoAnchors

active comparator: FEVAR

Fenestrated EndoVascular Aneurysm Repair

Interventions

ESAR treatment: Endograft + Heli-FX Endoanchor

ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor

FEVAR treatment : Fenestrated endograft

Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft

Primary outcome measure

Effectiveness Endpoint - Technical Success [ Time Frame: through 12 months post-procedure ]
Safety Endpoint - Freedom from Major Adverse Events [ Time Frame: through 30 days post-procedure ]

Central Contacts and Locations

Central contacts

Karlotta Knuth

+4915785318893 info@fcre.eu

Locations

UCSD Medical Center Hillcrest

Recruiting

La Jolla, California, United States, 92037

Stanford University

Recruiting

Stanford, California, United States, 94305

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Corewell Health (Spectrum)

Recruiting

Grand Rapids, Michigan, United States, 49503

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Oklahoma Heart

Recruiting

Tulsa, Oklahoma, United States, 74104

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 14212

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

More Information

Sponsor

FCRE (Foundation for Cardiovascular Research and Education)

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by FCRE (Foundation for Cardiovascular Research and Education) on 2026-05-22.