Clinical trial NCT00590759: Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms
Official title: A Clinical Evaluation of the GORE TAG Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm, Thoracic
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2008-01-11
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Aneurysm Related Death
timeFrame: 5 years
Secondary outcomes:
measure: A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.
timeFrame: 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Greeley
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Albany
country: United States
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
Study officials:
affiliation: St. Vincent's Healthcare, Billings MT
name: Mark Morasch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: