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

Overview

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

Full Title of Study: “A Clinical Study Evaluating the Use of the GORE EXCLUDER® AAA Endoprosthesis – 31mm In the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2008

Detailed Description

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.

Interventions

  • Device: 31 mm GORE EXCLUDER® AAA Endoprosthesis
    • GORE EXCLUDER® AAA Endoprosthesis – 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)

Arms, Groups and Cohorts

  • Experimental: 31 mm GORE EXCLUDER® Test Subjects
    • GORE EXCLUDER® AAA Endoprosthesis – 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • W.L.Gore & Associates
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jon S Matsumura, M.D., Principal Investigator, University of Wisconsin, Madison

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