Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

Overview

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:

  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

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Fahad Shuja, M.B.B.S.

Closed for enrollment

Contact information:

Laurel Schmeling M.B.A., C.C.R.C.

(507) 538-6419

Schmeling.Laurel@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20150013

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