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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: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Aortic Aneurysm, Thoracic
 Device: GORE TAG® Thoracic Endoprosthesis
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the GORE TAG® Thoracic Endoprosthesis - 45 mm for the Primary Treatment of Aneurysms of the Descending Thoracic Aorta

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • 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).


Enrollment: 23
Study Start Date: February 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thoracic Endograft
Gore 45mm TAG Thoracic Endograft Implantation
 Device: GORE TAG® Thoracic Endoprosthesis
Implant
Other Name: GORE TAG® Thoracic Endoprosthesis - 45 mm

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608829

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Michel Makaroun, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00608829     History of Changes
Other Study ID Numbers: TAG 06-02
Study First Received: December 20, 2007
Results First Received: August 18, 2010
Last Updated: August 2, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 23, 2013