GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta

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. Identifier: NCT00608829
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : September 15, 2010
Last Update Posted : March 5, 2015
Information provided by (Responsible Party):
W.L.Gore & Associates

December 20, 2007
February 6, 2008
August 18, 2010
September 15, 2010
March 5, 2015
February 2007
August 2009   (Final data collection date for primary outcome measure)
Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment [ Time Frame: one year ]
Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).
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Complete list of historical versions of study NCT00608829 on Archive Site
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GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta
Evaluation of the GORE TAG® Thoracic Endoprosthesis - 45 mm for the Primary Treatment of Aneurysms of the Descending Thoracic Aorta
The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.
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Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Aortic Aneurysm, Thoracic
Device: GORE TAG® Thoracic Endoprosthesis
Other Name: GORE TAG® Thoracic Endoprosthesis - 45 mm
Experimental: GORE TAG® Thoracic Endoprosthesis
Gore 45mm TAG Thoracic Endograft Implantation
Intervention: Device: GORE TAG® Thoracic Endoprosthesis
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2014
August 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair

    • Fusiform (≥50 mm), or
    • Saccular (no diameter criteria)
  2. All proximal and/or all distal landing zone inner diameters between 37-42 mm

    • Diameter taper between proximal and distal landing zones and the ability to use devices of different diameters to compensate for the taper must be within device sizing guide specifications
  3. Proximal and distal landing zone length greater than 2.0 cm

    • Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed
  4. Life expectancy > 2 years
  5. Subject is open surgical candidate defined as:

    • Able to tolerate thoracotomy
    • American Society of Anesthesiologists class I-IV (class V excluded)
    • New York Heart Association class I-III or not applicable (class IV excluded)
  6. Male or infertile female
  7. Age greater than 21 years
  8. Able to comply with study protocol requirements, including follow-up

Exclusion Criteria:

  1. Mycotic aneurysm
  2. Hemodynamically unstable aneurysm rupture
  3. Aortic dissection
  4. Planned occlusion of left carotid or celiac arteries
  5. Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date
  6. Myocardial infarction or stroke within 6 weeks of treatment
  7. Pre-treatment creatinine > 2.0 mg/dL
  8. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
  9. Participation in another drug or device study within 1 year of treatment
  10. History of drug abuse within 6 months of treatment
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
TAG 06-02
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W.L.Gore & Associates
W.L.Gore & Associates
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Principal Investigator: Michel Makaroun, MD University of Pittsburgh
W.L.Gore & Associates
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP