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

This study has been completed.
Information provided by (Responsible Party):
W.L.Gore & Associates Identifier:
First received: December 20, 2007
Last updated: March 23, 2015
Last verified: March 2015
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

Condition Intervention Phase
Aortic Aneurysm, Abdominal
Device: 31 mm GORE EXCLUDER® AAA Endoprosthesis
Phase 2

Study Type: Interventional
Study Design: 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:

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 1 Year [ Time Frame: Treatment through 1 year post-procedure (365 days) ]

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 1 year window post-procedure (through end of 1 year window, 546 days) ]

Enrollment: 35
Study Start Date: May 2006
Study Completion Date: June 2014
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 31 mm GORE EXCLUDER® Test Subjects
GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)
Device: 31 mm GORE EXCLUDER® AAA Endoprosthesis
GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)
Other Name: GORE EXCLUDER® Bifurcated Endoprosthesis

Detailed Description:
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.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00615069

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

Responsible Party: W.L.Gore & Associates 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: March 23, 2015

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases processed this record on May 22, 2017