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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00615069
First Posted: February 14, 2008
Last Update Posted: April 14, 2015
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.
Information provided by (Responsible Party):
W.L.Gore & Associates
  Purpose
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: None (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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00615069     History of Changes
Other Study ID Numbers: AAA 03-02
First Submitted: December 20, 2007
First Posted: February 14, 2008
Results First Submitted: March 26, 2009
Results First Posted: July 9, 2009
Last Update Posted: April 14, 2015
Last Verified: March 2015

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