Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms
NCT ID: NCT00590759
Last Updated: 2014-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2005-08-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GORE TAG® Thoracic Endoprosthesis
GORE TAG® Thoracic Endoprosthesis
implant
Interventions
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GORE TAG® Thoracic Endoprosthesis
implant
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Morasch, M.D.
Role: PRINCIPAL_INVESTIGATOR
St. Vincent's Healthcare, Billings MT
Locations
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Phoenix, Arizona, United States
Los Angeles, California, United States
San Francisco, California, United States
Greeley, Colorado, United States
Gainesville, Florida, United States
Miami, Florida, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Albany, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Temple, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
Vancouver, Washington, United States
Countries
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Other Identifiers
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TAG 05-02
Identifier Type: -
Identifier Source: org_study_id
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