Status:
COMPLETED
Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Aortic Aneurysm, Abdominal
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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 aor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00615069
Start Date
May 1 2006
End Date
June 1 2014
Last Update
April 14 2015
Active Locations (1)
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1
St. Vincent Healthcare
Billings, Montana, United States, 59101