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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00593814
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : August 23, 2010
Last Update Posted : January 8, 2018
Sponsor:
Information provided by:
W.L.Gore & Associates

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Abdominal Device: GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Endoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms
Study Start Date : June 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

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Arms and Interventions
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Intervention Details:
  • Device: GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability
    Implant

Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Number of Subjects With Device Efficacy Events [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593814


Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: Mark F Fillinger, MD Dartmouth-Hitchcock Medical Center
More Information
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Responsible Party: Lanesha Hill, WL Gore & Associates
ClinicalTrials.gov Identifier: NCT00593814    
Other Study ID Numbers: AAA 04-04
First Posted: January 15, 2008    Key Record Dates
Results First Posted: August 23, 2010
Last Update Posted: January 8, 2018
Last Verified: December 2017
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases