RECRUITING

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

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Conditions

Aortic Aneurysm, Abdominal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2021-05-21
Study Completion:2028-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04503395

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is \>18 years old
  2. * 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
  3. * Subject is not a candidate for safe, effective and durable standard EVAR due to challenging anatomical criteria as confirmed by the Core Lab screening
  4. * Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
  5. * Subject has provided written informed consent
  6. * 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
  7. * Proximal neck length of the aorta within 4-15mm and a minimum circumferential sealing zone of 8mm
  8. * Aortic neck diameter from 19 to 31mm
  9. * Infrarenal neck angulation ≤45°
  1. * Subject is participating in a concurrent study which may confound study results
  2. * Subject has a life expectancy \<2 year
  3. * Subject is female of childbearing potential in whom pregnancy cannot be excluded
  4. * Subject with eGFR \<30 mL/min/m2 (KDOQI classification - exclude class IV and above) and or on dialysis
  5. * Subject with a MI or CVA within 3 months prior to index procedure
  6. * Subject with known Connective Tissue Disease
  7. * Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to post-treatment
  8. * Subject who has undergone prior endovascular or open surgical treatment for abdominal aortic aneurysm
  9. * Subject requires emergent aneurysm treatment, for example, trauma or rupture
  10. * Subject has a known hypersensitivity or allergies to study device implant material
  11. * Subject has an aneurysm that is:
  12. * Suprarenal, pararenal, or thoracoabdominal
  13. * Mycotic
  14. * Inflammatory
  15. * Pseudoaneurysm
  16. * Subject is presenting with thrombus or calcification of the proximal aneurysm neck: circumferential \>50%
  17. * Pre-op stenosis of the renal arteries \> 50%
  18. * 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.

Contacts and Locations

Study Contact

Sarah Litterscheid, PhD
CONTACT
+49 15785319015
info@fcre.eu
Sarah Litterscheid
CONTACT
+49 15785319015
sarah.litterscheid@fcre.eu

Principal Investigator

Giovanni Torsello, Prof. Dr.
PRINCIPAL_INVESTIGATOR
Vascupedia
Brant Ullery, MD, MBA
PRINCIPAL_INVESTIGATOR
Medical Director, Vascular Surgery Providence Heart and Vascular Institute

Study Locations (Sites)

UCSD Medical Center Hillcrest
La Jolla, California, 92037
United States
Stanford University
Stanford, California, 94305
United States
University of Florida
Gainesville, Florida, 32608
United States
Corewell Health (Spectrum)
Grand Rapids, Michigan, 49503
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
United States
Oklahoma Heart
Tulsa, Oklahoma, 74104
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 14212
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-21
Study Completion Date2028-06-01

Study Record Updates

Study Start Date2021-05-21
Study Completion Date2028-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Aortic Aneurysm, Abdominal