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ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT04503395•FCRE (Foundation for Cardiovascular Research and Education)

View on ClinicalTrials.gov

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

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•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
+8 more criteria

Locations (32)

UCSD Medical Center Hillcrest

La Jolla, California, United States

Stanford University

Stanford, California, United States

University of Florida

Gainesville, Florida, United States

Corewell Health (Spectrum)

Grand Rapids, Michigan, United States

Mount Sinai Hospital

New York, New York, United States

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, United States

Oklahoma Heart

Tulsa, Oklahoma, United States

Providence Portland Medical Center

Portland, Oregon, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Key Dates

Start Date

May 21, 2021

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2028

Last Updated

April 30, 2025

Enrollment

204

ESTIMATED participants

Conditions

Aortic Aneurysm, Abdominal

Interventions

ESAR treatment: Endograft + Heli-FX Endoanchor

DEVICE

FEVAR treatment : Fenestrated endograft

DEVICE

Contacts

Sarah Litterscheid, PhD

CONTACT

+49 15785319015 info@fcre.eu

Sarah Litterscheid

CONTACT

+49 15785319015 sarah.litterscheid@fcre.eu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Inclusion Criteria

Exclusion Criteria

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