ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Description

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 Overview

Study Details

Study overview

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).

Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Condition
Aortic Aneurysm, Abdominal
Intervention / Treatment

-

Contacts and Locations

La Jolla

UCSD Medical Center Hillcrest, La Jolla, California, United States, 92037

Stanford

Stanford University, Stanford, California, United States, 94305

Gainesville

University of Florida, Gainesville, Florida, United States, 32608

Grand Rapids

Corewell Health (Spectrum), Grand Rapids, Michigan, United States, 49503

New York

Mount Sinai Hospital, New York, New York, United States, 10029

Charlotte

Atrium Health Carolinas Medical Center, Charlotte, North Carolina, United States, 28203

Tulsa

Oklahoma Heart, Tulsa, Oklahoma, United States, 74104

Portland

Providence Portland Medical Center, Portland, Oregon, United States, 97213

Pittsburgh

Allegheny General Hospital, Pittsburgh, Pennsylvania, United States, 14212

Norfolk

Sentara Norfolk General Hospital, Norfolk, Virginia, United States, 23507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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°
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

FCRE (Foundation for Cardiovascular Research and Education),

Giovanni Torsello, Prof. Dr., PRINCIPAL_INVESTIGATOR, Vascupedia

Brant Ullery, MD, MBA, PRINCIPAL_INVESTIGATOR, Medical Director, Vascular Surgery Providence Heart and Vascular Institute

Study Record Dates

2028-06-01