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

Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:21 - Any
Start Date:December 19, 2017
End Date:December 2024
Contact:Arthur Scott
Phone:(623) 234-5263

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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

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.

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,

- 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

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

12. Known history of drug abuse

13. Known sensitivities or allergies to the device materials
We found this trial at
4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
Brooklyn, NY
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8900 North Kendall Drive
Miami, Florida 33176
Miami, FL
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Jacksonville, Florida 32207
Jacksonville, FL
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Knoxville, Tennessee 37920
Knoxville, TN
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600 North Cattlemen Road
Sarasota, Florida 34232
Sarasota, FL
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