Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:12/6/2018
Start Date:October 2013
End Date:September 2021

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Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms

The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized,
multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE
Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).


Inclusion Criteria:

1. Common iliac aneurysm with or without concomitant abdominal aortic aneurysm

2. Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses

3. An Informed Consent Form signed by Subject or legally authorized representative

4. Male or infertile female

5. Able to comply with protocol requirements including following-up

6. Life expectancy > 2 years

7. Age > 21 years

8. Surgical candidate

Exclusion Criteria:

1. Mycotic or ruptured aneurysm

2. Known concomitant thoracic aortic aneurysm which requires intervention

3. American Society of Anesthesiologists (ASA) Physical Status classification system
class V (moribund patient not expected to live 24 hours with or without operation)

4. Renal insufficiency defined or patient undergoing dialysis

5. New York Heart Association (NYHA) Functional Classification class IV

6. Dissected, heavily calcified, or heavily thrombosed landing zone(s)

7. Tortuous or stenotic iliac and/or femoral arteries

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
We found this trial at
1
site
New York, New York 10065
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from
New York, NY
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