Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

Running, not enrolling · Not applicable

Conditions studied: Aortic Aneurysm, Abdominal

In brief

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.

Key facts

Study ID

NCT02489539

Run by

W.L.Gore & Associates

People needed

175

Starts

2017-12-19

Expected to finish

2027-12-31

Last updated by the study team

2025-08-13

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Mycotic or ruptured aneurysm
• Known concomitant thoracic aortic aneurysm which requires surgical intervention
• Renal insufficiency defined as creatinine > 2.5 mg/dL or patient undergoing dialysis
• New York Heart Association (NYHA) class IV
• Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
• Severely tortuous or stenotic iliac and / or femoral arteries
• Patient has body habitus or other medical condition which prevents adequate delineation of the aorta
• Participating in another investigational device or drug study within 1 year of treatment
• Systemic infection which may increase the risk of endovascular graft infection
• Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
• Planned concomitant surgical procedure or major surgery within 30 days of treatment date
• Known history of drug abuse
• Known sensitivities or allergies to the device materials

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• Leland Stanford Junior University — Stanford, California, United States
• River City Clinical Research — Jacksonville, Florida, United States
• Baptist Cardiac and Vascular Institute — Miami, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Sarasota Vascular Specialists — Sarasota, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Vascular Surgical Associates, PC — Marietta, Georgia, United States
• Loyola University - Chicago — Maywood, Illinois, United States
• Southern Illinois University — Springfield, Illinois, United States
• University of Iowa Hospitals & Clinic — Iowa City, Iowa, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Spectrum Health System — Grand Rapids, Michigan, United States
• Essentia Institute of Rural Health — Duluth, Minnesota, United States
• Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• Minneapolis Radiology and Vascular Research Foundation — Plymouth, Minnesota, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine - St. Louis — St Louis, Missouri, United States
• Mercy Research — St Louis, Missouri, United States
• The Hitchcock Foundation — Lebanon, New Hampshire, United States
• AHA Hospital Corp. — Morristown, New Jersey, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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