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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00615069
First received: December 20, 2007
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

The safety and efficacy for the large diameter 31mm EXCLUDER will be superior to surgical repair and comparable to that of the approved EXCLUDER device.


Condition Intervention Phase
Aortic Aneurysm, Abdominal
 Device: GORE EXCLUDER AAA Endoprosthesis
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Study Evaluating the Use of the GORE EXCLUDER® AAA Endoprosthesis - 31mm 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:
  • Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 12 Months Post-procedure. [ Time Frame: Treatment through 12 months post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications [ Time Frame: Treatment through 12 months post-procedure ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: May 2006
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abdominal Endograft
GORE EXCLUDER® Bifurcated Endoprosthesis
 Device: GORE EXCLUDER AAA Endoprosthesis
Implant
Other Name: GORE EXCLUDER® Bifurcated Endoprosthesis

Detailed Description:

The primary objective of this study is 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 to compare device performance of the original GORE EXCLUDER® AAA Endoprostheses to the 31mm EXCLUDER when used in the treatment of infrarenal abdominal aortic aneurysms will also be performed.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615069

Locations
United States, Montana
St. Vincent Healthcare
Billings, Montana, United States, 59101
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Jon S Matsumura, M.D. University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00615069     History of Changes
Other Study ID Numbers: AAA 03-02
Study First Received: December 20, 2007
Results First Received: March 26, 2009
Last Updated: December 19, 2012
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