Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms
A Clinical Evaluation of the GORE TAG Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms
1 other identifier
interventional
150
1 country
25
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2005
Longer than P75 for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
August 7, 2014
CompletedAugust 7, 2014
August 1, 2014
7.7 years
December 20, 2007
June 10, 2014
August 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Aneurysm Related Death
Freedom from aneurysm related mortality for TAG 05-02 subjects
5 years
Secondary Outcomes (1)
A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.
5 years
Study Arms (1)
GORE TAG® Thoracic Endoprosthesis
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Descending thoracic aortic aneurysm deemed to warrant surgical repair:
- Fusiform aneurysm greater than or equal to 2 times diameter of normal adjacent aorta
- Saccular aneurysm
- Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A)
- 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
- Life expectancy \> 2 years
- Surgical Candidate
- ASA Class I, II, III, or IV
- NYHA Class I, II, III or no heart disease
- Male or infertile female
- Minimum 21 years of age
- Able to comply with protocol requirements
- Signed Informed Consent Form
You may not qualify if:
- mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta
- Significant thrombus at the proximal or distal implantation zones
- Mycotic aneurysm
- Hemodynamically unstable aneurysm rupture (non-contained aneurysm rupture)
- Acute or chronic aortic dissection
- Planned occlusion of the left carotid or celiac arteries
- "Planned" concomitant surgical procedure (other than left subclavian transposition) or previous major surgery within 30 days
- Myocardial infarction or cerebral vascular accident within 6 weeks
- Severe respiratory insufficiency sufficient that precludes open thoracotomy
- Renal insufficiency (Creatinine \> 2.0 mg/dL) with or without dialysis
- Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
- Participation in another investigational device or drug study within 1 year
- Documented history of drug abuse within 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Greeley, Colorado, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Peoria, Illinois, United States
Unknown Facility
Kansas City, Kansas, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Albany, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Temple, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Charlottesville, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Vancouver, Washington, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Makowsky
- Organization
- W. L. Gore and Associates, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Morasch, M.D.
St. Vincent's Healthcare, Billings MT
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
January 11, 2008
Study Start
August 1, 2005
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
August 7, 2014
Results First Posted
August 7, 2014
Record last verified: 2014-08