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

This study has been completed.
Sponsor:
Information provided by:
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00593814
First received: December 20, 2007
Last updated: July 13, 2010
Last verified: July 2010
History of Changes
  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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 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: June 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability
    Implant
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: Lanesha Hill, WL Gore & Associates
ClinicalTrials.gov Identifier: NCT00593814     History of Changes
Other Study ID Numbers: AAA 04-04
Study First Received: December 20, 2007
Results First Received: April 20, 2010
Last Updated: July 13, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 22, 2013