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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Aortic Aneurysm, Abdominal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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31 mm GORE EXCLUDER® Test Subjects

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

Group Type EXPERIMENTAL

31 mm GORE EXCLUDER® AAA Endoprosthesis

Intervention Type DEVICE

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

Interventions

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31 mm GORE EXCLUDER® AAA Endoprosthesis

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

Intervention Type DEVICE

Other Intervention Names

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GORE EXCLUDER® Bifurcated Endoprosthesis

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No