Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

W.L. Gore & Associates

Status: Completed

Conditions: Common Iliac Artery Aneurysms; Aorto-iliac Aneurysms

Treatments: Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT01883999

IBE 12-04

Details and patient eligibility

About

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).

Enrollment: 64 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Experimental group

Description:

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Treatment:

Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis