Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
Key facts
- Where
- Ann Arbor, Asheville, Atlanta, Birmingham, Brooklyn, Buffalo, Charleston, Charlottesville, Cincinnati, Cleveland, Columbus, Duluth, Durham, Grand Rapids, Greensboro, Greenville, Houston, Iowa City, Jacksonville, Knoxville, Lebanon, Los Angeles, Madison, Marietta, Maywood, Miami, Milwaukee, Minneapolis, Morristown, Nashville, New Orleans, Norfolk, Oklahoma City, Orlando, Phoenix, Pittsburgh, Plymouth, Providence, Raleigh, Rochester, Sarasota, Sioux Falls, Springfield, St Louis, Stanford, Staten Island, and Virginia Beach, United StatesSee the 51 sites
Where in United States
- University of MichiganAnn Arbor, United StatesNo longer taking part
- Mission HospitalAsheville, United StatesNo longer taking part
- Emory UniversityAtlanta, United StatesNo longer taking part
- University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
- Maimonides Medical CenterBrooklyn, United StatesNo longer taking part
- Research Foundation SUNY BuffaloBuffalo, United StatesNo longer taking part
- CAMC Health Education and Research Institute IncCharleston, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- University of VirginiaCharlottesville, United StatesNo longer taking part
- Good Samaritan Hospital - CincinnatiCincinnati, United StatesNo longer taking part
- Cleveland Clinic FoundationCleveland, United StatesNo longer taking part
- Ohio Health Research InstituteColumbus, United StatesNo longer taking part
- Essentia Institute of Rural HealthDuluth, United StatesNo longer taking part
- Duke University Medical CenterDurham, United StatesNo longer taking part
- Spectrum Health SystemGrand Rapids, United StatesNo longer taking part
- Moses Cone Memorial HospitalGreensboro, United StatesNo longer taking part
- Prisma Health-UpstateGreenville, United StatesNo longer taking part
- Texas Heart Institute / Baylor St. Luke's Medical CenterHouston, United StatesNo longer taking part
- The Methodist Hospital - HoustonHouston, United StatesNo longer taking part
- University of Iowa Hospitals & ClinicIowa City, United StatesNo longer taking part
- River City Clinical ResearchJacksonville, United StatesNo longer taking part
- University of TennesseeKnoxville, United StatesNo longer taking part
- The Hitchcock FoundationLebanon, United StatesNo longer taking part
- University of Southern CaliforniaLos Angeles, United StatesNo longer taking part
- University of Wisconsin SystemMadison, United StatesNo longer taking part
- Vascular Surgical Associates, PCMarietta, United StatesNo longer taking part
- Loyola University ChicagoMaywood, United StatesNo longer taking part
- Baptist Cardiac and Vascular InstituteMiami, United StatesNo longer taking part
- Aurora Health Care, Metro Inc.Milwaukee, United StatesNo longer taking part
- Minneapolis Heart Institute Foundation - Abbott Northwestern HospitalMinneapolis, United StatesNo longer taking part
- AHA Hospital Corp.Morristown, United StatesNo longer taking part
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
- Ochsner Clinic FoundationNew Orleans, United StatesNo longer taking part
- Sentara Medical GroupNorfolk, United StatesNo longer taking part
- Oklahoma Heart Hospital Research FoundationOklahoma City, United StatesNo longer taking part
- Florida HospitalOrlando, United StatesNo longer taking part
- Mayo Clinic - ArizonaPhoenix, United StatesNo longer taking part
- University of Pittsburgh Medical CenterPittsburgh, United StatesNo longer taking part
- Minneapolis Radiology and Vascular Research FoundationPlymouth, United StatesNo longer taking part
- Rhode Island HospitalProvidence, United StatesNo longer taking part
- NC Heart and Vascular Research, LLCRaleigh, United StatesNo longer taking part
- Mayo Clinic - RochesterRochester, United StatesNo longer taking part
- Sarasota Vascular SpecialistsSarasota, United StatesNo longer taking part
- North Central Heart Institute, Ltd.Sioux Falls, United StatesNo longer taking part
- Sanford Clinic - Clinic ResearchSioux Falls, United StatesNo longer taking part
- Southern Illinois UniversitySpringfield, United StatesNo longer taking part
- Mercy ResearchSt Louis, United StatesNo longer taking part
- Washington University School of Medicine - St. LouisSt Louis, United StatesNo longer taking part
- Leland Stanford Junior UniversityStanford, United StatesNo longer taking part
- Staten Island University HospitalStaten Island, United StatesNo longer taking part
- Inova Cardiology-FairfaxVirginia Beach, United StatesNo longer taking part
Trial details
- Who runs it
- W.L.Gore & Associates
- Trial code
- NCT02489539
- Record updated
- 13 August 2025
- Original description
The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.Read full original descriptionShow less
The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.
Inclusion: AAA meeting any of the following criteria:; Maximum diameter ≥50 mm; Rapid growth (>5 mm in a 6 month period); Non-ruptured AAA presenting with clinical symptoms; Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis, including:; Adequate iliac / femoral access; Infrarenal aortic neck diameter 16-32 mm; Infrarenal aortic neck length ≥10 mm; Aortic neck angle ≤ 90˚; Distal iliac artery seal zone ≥10 mm; Iliac artery diameter 8-25 mm; An Informed Consent Form (ICF) signed by Subject; Male or infertile female; Able to comply with Protocol requirements including following-up; Life expectancy > 2 years; Age ≥ 21 years.
Exclusion: Known concomitant thoracic aortic aneurysm which requires surgical intervention; Participating in another investigational device or drug study within 1 year of treatment; Planned concomitant surgical procedure or major surgery within 30 days of treatment date; New York Heart Association (NYHA) class IV; Patient has body habitus or other medical condition which prevents adequate delineation of the aorta; Systemic infection which may increase the risk of endovascular graft infection; Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome; Known history of drug abuse; Known sensitivities or allergies to the device materials; Renal insufficiency defined as creatinine > 2.5 mg/dL or patient undergoing dialysis; Mycotic or ruptured aneurysm; Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s); Severely tortuous or stenotic iliac and / or femoral arteries.