Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

Study Overview
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Brief Summary
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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).

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

Conditions
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Common Iliac Artery Aneurysms, Aorto-iliac Aneurysms

Intervention / Treatment
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* Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GORE® EXCLUDER® Iliac Branch Endoprosthesis<br>GORE® EXCLUDER® Iliac Branch Endoprosthesis | Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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). | Through 6 month follow-up visit |