Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-004298
NCT ID: NCT01883999
Sponsor Protocol Number: IBE 12-04
About this study
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).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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)
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Fahad Shuja, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available