Status:
COMPLETED
Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Common Iliac Artery Aneurysms
Aorto-iliac Aneurysms
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
- Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses
- An Informed Consent Form signed by Subject or legally authorized representative
- Male or infertile female
- Able to comply with protocol requirements including following-up
- Life expectancy \> 2 years
- Age \> 21 years
- Surgical candidate
Exclusion
- Mycotic or ruptured aneurysm
- Known concomitant thoracic aortic aneurysm which requires intervention
- American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation)
- Renal insufficiency defined or patient undergoing dialysis
- New York Heart Association (NYHA) Functional Classification class IV
- Dissected, heavily calcified, or heavily thrombosed landing zone(s)
- Tortuous or stenotic iliac and/or femoral arteries
- Participating in another investigational device or drug study within 1 year of treatment
- Systemic infection which may increase the risk of endovascular graft infection
- Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
- Planned concomitant surgical procedure or major surgery within 30 days of treatment date
- Known history of drug abuse
- Known sensitivities or allergies to the device materials
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01883999
Start Date
October 1 2013
End Date
June 1 2021
Last Update
November 2 2021
Active Locations (1)
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1
Weill Cornell Medical Center
New York, New York, United States, 10065