Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis (NCT01883999) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis
United States64 participantsStarted 2013-10
Plain-language 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 common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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)
What they're measuring
1
Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair
Timeframe: 30 days post-treatment
2
Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC