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

Phase 2

Completed

• Conditions: Aortic Aneurysm, Abdominal

• Registration Number: NCT00615069
• Lead Sponsor: W.L.Gore & Associates

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2008-02-01
• Study First Posted: 2008-02-14
• Primary Completion: 2008-03
• Results First Submitted: 2009-03-26
• Results First Submitted QC: 2009-05-18
• Results First Posted: 2009-07-09
• Study Completion: 2014-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

St. Vincent Healthcare; 🇺🇸 Billings, Montana, United States