GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms

Phase 4

Completed

• Conditions: Aortic Aneurysm, Abdominal

• Registration Number: NCT00593814
• Lead Sponsor: W.L.Gore & Associates

Brief Summary

The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2008-01-03
• Study First Posted: 2008-01-15
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2010-04-20
• Results First Submitted QC: 2010-07-13
• Results First Posted: 2010-08-23
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-08
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

1. Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter
2. Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use
3. Access vessel able to receive 18 French introducer sheath
4. Life expectancy > 2 years
5. Appropriate candidate for endovascular repair
6. Ability to comply with protocol requirements including follow-up
7. 21 years of age or older, male or infertile female**

Exclusion Criteria

1. Mycotic or ruptured aneurysm
2. Participating in another investigational device or drug study within one year
3. Documented history of drug abuse within six months
4. Myocardial infarction or cerebral vascular accident within six weeks
5. Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function
6. Iliac anatomy that would require occlusion of both internal iliac arteries
7. Planned occlusion or reimplantation of significant mesenteric or renal arteries
8. Planned concomitant surgical procedure or previous major surgery within 30 days
9. Previous prosthesis placement in the aorta or iliac arteries
10. Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure	2 years

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Device Efficacy Events	2 years