NCT02489539

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

Official Title:

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

Summary

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.

Eligibility

Inclusion Criteria:

1. 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
2. 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
3. An Informed Consent Form (ICF) signed by Subject
4. Male or infertile female
5. Able to comply with Protocol requirements including following-up
6. Life expectancy > 2 years
7. 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

Disease(s) and\or Condition(s)

Aortic Aneurysm, Abdominal

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DEVICE
    • Name: GORE® EXCLUDER® Conformable AAA Endoprosthesis
    • Description: 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.
    • Arm Group Labels: High Neck Angulation Substudy, Short Neck Substudy
Sponsor
  • W.L.Gore & Associates