Purpose

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.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. AAA meeting any of the following criteria:
  2. Maximum diameter ≥50 mm
  3. Rapid growth (>5 mm in a 6 month period)
  4. Non-ruptured AAA presenting with clinical symptoms
  5. Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis, including:
  6. Adequate iliac / femoral access
  7. Infrarenal aortic neck diameter 16-32 mm
  8. Infrarenal aortic neck length ≥10 mm
  9. Aortic neck angle ≤ 90˚
  10. Distal iliac artery seal zone ≥10 mm
  11. Iliac artery diameter 8-25 mm
  12. An Informed Consent Form (ICF) signed by Subject
  13. Male or infertile female
  14. Able to comply with Protocol requirements including following-up
  15. Life expectancy > 2 years
  16. Age ≥ 21 years

Exclusion Criteria

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Short Neck Substudy
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
  • Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis
    Endovascular Aneurysm repair (EVAR) is a minimally invasive procedure designed to exclude an aneurysmal segment of the aorta from blood circulation. The EVAR procedure involves delivery of a stent- graft compressed onto a catheter to an aneurysmal segment of the aorta from a remote access site, generally the femoral artery. Arterial access may be done by either percutaneous or cut-down technique.
Experimental
High Neck Angulation Substudy
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation > 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
  • Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis
    Endovascular Aneurysm repair (EVAR) is a minimally invasive procedure designed to exclude an aneurysmal segment of the aorta from blood circulation. The EVAR procedure involves delivery of a stent- graft compressed onto a catheter to an aneurysmal segment of the aorta from a remote access site, generally the femoral artery. Arterial access may be done by either percutaneous or cut-down technique.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Benjamin Pearce, MD

More Details

Status
Recruiting
Sponsor
W.L.Gore & Associates

Study Contact

Asia Harris
(623) 234-5668
asharris@wlgore.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.