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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00608829
First received: December 20, 2007
Last updated: September 23, 2013
Last verified: September 2013

December 20, 2007
September 23, 2013
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 ] [ Designated as safety issue: Yes ]
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).
Not Provided
Complete list of historical versions of study NCT00608829 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Aneurysm, Thoracic
Device: GORE TAG® Thoracic Endoprosthesis
Implant
Other Name: GORE TAG® Thoracic Endoprosthesis - 45 mm
Experimental: Thoracic Endograft
Gore 45mm TAG Thoracic Endograft Implantation
Intervention: Device: GORE TAG® Thoracic Endoprosthesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
23
December 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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00608829
TAG 06-02
No
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Principal Investigator: Michel Makaroun, MD University of Pittsburgh
W.L.Gore & Associates
September 2013

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