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

  • End date
    Dec 31, 2026
  • participants needed
  • sponsor
    W.L.Gore & Associates
Updated on 18 May 2022
aortic aneurysm


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.


The study design is a prospective, nonrandomized, international, multicenter study comprised of two parallel substudies. The total subject population will be 190 subjects with 80 subjects assigned to the Short Neck Substudy and 110 subjects to the High Neck Angulation Substudy.

This clinical study will include fifty-six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams and contrast-enhanced computed tomography (CT) scans at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Conformable AAA Endoprosthesis implant. Each Substudy will be evaluated and reported independently from each other according to the Safety and Effectiveness Endpoints. No comparative analyses between these substudies are planned.

Condition Aortic Aneurysm, Abdominal
Treatment GORE® EXCLUDER® Conformable AAA Endoprosthesis
Clinical Study IdentifierNCT02489539
SponsorW.L.Gore & Associates
Last Modified on18 May 2022


Yes No Not Sure

Inclusion Criteria

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
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 Criteria

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
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