Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER® AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms

Detailed Description
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The primary objective of this study was to estimate the safety of the 31 mm GORE EXCLUDER® AAA Endoprosthesis as compared to open surgical repair when used in the treatment of infrarenal abdominal aortic aneurysms. A secondary objective was to compare device performance of the original GORE EXCLUDER® AAA Endoprosthesis to the 31mm EXCLUDER when used in the treatment of infrarenal abdominal aortic aneurysms.

Official Title
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A Clinical Study Evaluating the Use of the GORE EXCLUDER® AAA Endoprosthesis - 31mm In the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms

Conditions
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Aortic Aneurysm, Abdominal

Intervention / Treatment
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* Device: 31 mm GORE EXCLUDER® AAA Endoprosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infrarenal AAA > or equal to 4.5 cm in diameter Proximal infrarenal aortic neck length > or equal 15mm Anatomy meets 31mm EXCLUDER specification criteria Access vessel able to receive 20 Fr. introducer sheath Life expectancy >2 years Surgical candidate ASA Class I, II, III, or IV NYHA Class I, II, III 21 years of age or older Male or infertile female Ability to comply with protocol requirements including follow-up Signed Informed Consent Form Exclusion Criteria: Mycotic or ruptured aneurysm Participating in another investigational device or drug study within 1 year Documented history of drug abuse within 6 months Coexisting thoracic aortic aneurysm (50% larger than proximal aorta) Myocardial infarction or cerebral vascular accident within 6 weeks Pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate due to pulmonary function Renal insufficiency (Creatinine > 2.5 mg/dL) without dialysis Iliac anatomy that would require occlusion of both internal iliac arteries Planned occlusion or reimplantation of significant mesenteric or renal arteries Planned concomitant surgical procedure or previous major surgery within 30 days Previous prosthesis placement in the same position of the aorta or iliac arteries Degenerative connective tissue disease, e.g., Marfans and Ehlers Danlos Syndrome Proximal neck angulation > 60 degrees Presence of significant thrombus at arterial implantation sites

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: 31 mm GORE EXCLUDER® Test Subjects<br>GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA) | Device: 31 mm GORE EXCLUDER® AAA Endoprosthesis<br>* GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)<br>* Other names: GORE EXCLUDER® Bifurcated Endoprosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year |  | Treatment through 1 year post-procedure (365 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications |  | Treatment through 1 year window post-procedure (through end of 1 year window, 546 days) |