Clinical Trial: Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).

Detailed Summary:
Sponsor: W.L.Gore & Associates

Current Primary Outcome:

  • Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair [ Time Frame: 30 days post-treatment ]
    Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.
  • 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 [ Time Frame: Through 6 month follow-up visit ]

    Freedom from all of the following:

    • Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) due to Type I/III endoleak as determined by Clinical Events Committee (CEC).
    • Complete loss of blood flow in leg of IBC or IIC as assessed by Core Laboratory
    • Reintervention on IBC or IIC to re-establish patency due to 60% occlusion or greater as determined by CEC.


Original Primary Outcome:

Current Secondary Outcome: Freedom From New Onset Buttock Claudication Arising From the Side of the Body Treated With the Iliac Branch Component (IBC) and Internal Iliac Component (IIC) [ Time Frame: Through 6 month follow-up visit ]

Freedom from new onset buttock claudication arising from the side of the body treated with the Iliac Branch Component (IBC) and Internal Iliac Component (IIC).


Original Secondary Outcome:

Information By: W.L.Gore & Associates

Dates:
Date Received: June 18, 2013
Date Started: October 2013
Date Completion:
Last Updated: October 7, 2016
Last Verified: October 2016