Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms

Completed · Not applicable

Conditions studied: Aortic Aneurysm, Thoracic

In brief

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

Key facts

Study ID

NCT00590759

Run by

W.L.Gore & Associates

People needed

150

Starts

2005-08-01

Expected to finish

2013-04-01

Last updated by the study team

2014-08-07

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Descending thoracic aortic aneurysm deemed to warrant surgical repair:
• Fusiform aneurysm greater than or equal to 2 times diameter of normal adjacent aorta
• Saccular aneurysm
• Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A)
• 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
• Life expectancy > 2 years
• Surgical Candidate
• ASA Class I, II, III, or IV
• NYHA Class I, II, III or no heart disease
• Male or infertile female
• Minimum 21 years of age
• Able to comply with protocol requirements
• Signed Informed Consent Form

You may not qualify if…

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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Greeley, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Albany, New York, United States
• Study site — New York, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Memphis, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Temple, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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