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

Phase 2

Completed

• Conditions: Aortic Aneurysm, Abdominal
• Interventions: Device: 31 mm GORE EXCLUDER® AAA Endoprosthesis

• 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

Arm && Interventions

Group	Intervention	Description
31 mm GORE EXCLUDER® Test Subjects	31 mm GORE EXCLUDER® AAA Endoprosthesis	GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)

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