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Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of 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: NCT00590759
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Brief Summary:
The purpose of this post-approval study is to evaluate the long-term performance of the GORE TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic aortic (DTA) aneurysms

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Thoracic Device: GORE TAG® Thoracic Endoprosthesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the GORE TAG Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms
Study Start Date : August 2005
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
GORE TAG® Thoracic Endoprosthesis Device: GORE TAG® Thoracic Endoprosthesis
implant




Primary Outcome Measures :
  1. Aneurysm Related Death [ Time Frame: 5 years ]
    Freedom from aneurysm related mortality for TAG 05-02 subjects


Secondary Outcome Measures :
  1. A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair. [ Time Frame: 5 years ]
    Proportion of subjects in TAG 05-02 with MAEs



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Descending thoracic aortic aneurysm deemed to warrant surgical repair:

    1. Fusiform aneurysm greater than or equal to 2 times diameter of normal adjacent aorta
    2. Saccular aneurysm
  2. Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A)
  3. Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm

    • <60 degree angle in the aortic arch may require additional length of non-aneurysmal segment if the arch is included in the treatment segment

  4. Life expectancy > 2 years
  5. Surgical Candidate

    • ASA Class I, II, III, or IV
    • NYHA Class I, II, III or no heart disease
  6. Male or infertile female
  7. Minimum 21 years of age
  8. Able to comply with protocol requirements
  9. Signed Informed Consent Form

Exclusion Criteria:

  1. 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta
  2. Significant thrombus at the proximal or distal implantation zones
  3. Mycotic aneurysm
  4. Hemodynamically unstable aneurysm rupture (non-contained aneurysm rupture)
  5. Acute or chronic aortic dissection
  6. Planned occlusion of the left carotid or celiac arteries
  7. "Planned" concomitant surgical procedure (other than left subclavian transposition) or previous major surgery within 30 days
  8. Myocardial infarction or cerebral vascular accident within 6 weeks
  9. Severe respiratory insufficiency sufficient that precludes open thoracotomy
  10. Renal insufficiency (Creatinine > 2.0 mg/dL) with or without dialysis
  11. Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
  12. Participation in another investigational device or drug study within 1 year
  13. Documented history of drug abuse within 6 months

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): NCT00590759


Locations
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United States, Arizona
Phoenix, Arizona, United States
United States, California
Los Angeles, California, United States
San Francisco, California, United States
United States, Colorado
Greeley, Colorado, United States
United States, Florida
Gainesville, Florida, United States
Miami, Florida, United States
United States, Illinois
Chicago, Illinois, United States
Peoria, Illinois, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
Albany, New York, United States
New York, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Memphis, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Temple, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Charlottesville, Virginia, United States
United States, Washington
Seattle, Washington, United States
Vancouver, Washington, United States
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: Mark Morasch, M.D. St. Vincent's Healthcare, Billings MT
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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00590759    
Other Study ID Numbers: TAG 05-02
First Posted: January 11, 2008    Key Record Dates
Results First Posted: August 7, 2014
Last Update Posted: August 7, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases