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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00590759
First received: December 20, 2007
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the GORE TAG Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Aneurysm related death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • A subset of major Adverse Events will be evaluated in subjects treated with the TAG device and subjects treated with open surgical repair. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: August 2005
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Thoracic Endograft
Gore TAG Thoracic Endoprosthesis
Device: GORE TAG® Thoracic Endoprosthesis
implant

  Eligibility

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

Inclusion Criteria:

  1. Descending thoracic aortic aneurysm deemed to warrant surgical repair:

    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:

  1. 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590759

  Show 25 Study Locations
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Mark Morasch, M.D. St. Vincent's Healthcare, Billings MT
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00590759     History of Changes
Other Study ID Numbers: TAG 05-02
Study First Received: December 20, 2007
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014