Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

  • Interventional
  • Recruiting
  • NCT01883999
Eligibility Details Visit Clinicaltrials.gov

Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms

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).

Gender
All

Age Group
21 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT01883999

IRB#IRB14-0791

Lead SponsorW.L.Gore & Associates

Lead PhysicianChristopher L. Skelly

Collaborator(s)N/A

EligibilityAll
21 Years and up
Recruiting