COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

Brief Summary:
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 or disease Intervention/treatment Phase
Aortic Aneurysm, Thoracic Device: GORE TAG® Thoracic Endoprosthesis Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: GORE TAG® Thoracic Endoprosthesis
Gore 45mm TAG Thoracic Endograft Implantation
Device: GORE TAG® Thoracic Endoprosthesis
Other Name: GORE TAG® Thoracic Endoprosthesis - 45 mm

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00608829

Layout table for location information
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
W.L.Gore & Associates
Layout table for investigator information
Principal Investigator: Michel Makaroun, MD University of Pittsburgh Medical Center
Layout table for additonal information
Responsible Party: W.L.Gore & Associates Identifier: NCT00608829    
Other Study ID Numbers: TAG 06-02
First Posted: February 6, 2008    Key Record Dates
Results First Posted: September 15, 2010
Last Update Posted: March 5, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases