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

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

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm, Thoracic
• Intervention / Treatment: Device: GORE TAG® Thoracic Endoprosthesis

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States
  • California
    • Los Angeles, California, United States
    • San Francisco, California, United States
  • Colorado
    • Greeley, Colorado, United States
  • Florida
    • Gainesville, Florida, United States
    • Miami, Florida, United States
  • Illinois
    • Chicago, Illinois, United States
    • Peoria, Illinois, United States
  • Kansas
    • Kansas City, Kansas, United States
  • Louisiana
    • New Orleans, Louisiana, United States
  • Massachusetts
    • Boston, Massachusetts, United States
  • Missouri
    • St. Louis, Missouri, United States
  • New York
    • Albany, New York, United States
    • New York, New York, United States
  • North Carolina
    • Durham, North Carolina, United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
    • Pittsburgh, Pennsylvania, United States
  • Tennessee
    • Memphis, Tennessee, United States
    • Nashville, Tennessee, United States
  • Texas
    • Dallas, Texas, United States
    • Temple, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Virginia
    • Charlottesville, Virginia, United States
  • Washington
    • Seattle, Washington, United States
    • Vancouver, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: GORE TAG® Thoracic Endoprosthesis	Device: GORE TAG® Thoracic Endoprosthesis; implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aneurysm Related Death	Freedom from aneurysm related mortality for TAG 05-02 subjects	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.	Proportion of subjects in TAG 05-02 with MAEs	5 years

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Mark Morasch, M.D., St. Vincent's Healthcare, Billings MT

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: January 10, 2008
• First Posted (Estimate): January 11, 2008

Study Record Updates

• Last Update Posted (Estimate): August 7, 2014
• Last Update Submitted That Met QC Criteria: August 6, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: TAG 05-02