GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of AAA

This study is ongoing, but not recruiting participants.

First Received: December 20, 2007 Last Updated: January 3, 2008 History of Changes

Sponsored by:	W.L.Gore & Associates
Information provided by:	W.L.Gore & Associates
ClinicalTrials.gov Identifier:	NCT00593814

Purpose

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.

Condition	Intervention	Phase
Aortic Aneurysm, Abdominal	Device: GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability	Phase IV

MedlinePlus related topics: Aneurysms Aortic Aneurysm

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Enodoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:

Incidence of aneurysm volume increase greater than 10% as compared to the 1-month baseline from to the original GORE EXCLUDER® through 2 years post-procedure [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Device Efficacy Events [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	139
Study Start Date:	May 2005
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Implant

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Infrarenal AAA less than 4.5 cm in diameter
Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per IFU
Access vessel able to receive 18 Fr. introducer sheath
Life expectancy > 2 years
Appropriate candidate for endovascular repair
Ability to comply with protocol requirements including follow-up
21 years of age or older, male or infertile female**

Exclusion Criteria:

Mycotic or ruptured aneurysm
Participating in another investigational device or drug study within one year
Documented history of drug abuse within six months
Myocardial infarction or cerebral vascular accident within six weeks
Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function
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 aorta or iliac arteries
Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593814

Sponsors and Collaborators

W.L.Gore & Associates

Investigators

Principal Investigator:

Mark F Fillinger, MD

Dartmouth-Hitchcock Medical Center

More Information

No publications provided

Responsible Party:	WL Gore & Associates ( Erin Tims )
Study ID Numbers:	AAA 04-04
Study First Received:	December 20, 2007
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00593814 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Aortic Aneurysm
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:

Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm

ClinicalTrials.gov processed this record on May 07, 2009