N/A N=150 Treatment

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

Aortic Aneurysm, Thoracic

Bottom Line

View on ClinicalTrials.gov: NCT00590759 ↗

Enrolled (actual)

150

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Aneurysm Related Death — 4 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: GORE TAG® Thoracic Endoprosthesis (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: W.L.Gore & Associates
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Aneurysm Related Death	4	—
SECONDARY A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.	22	—

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

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
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

Exclusion Criteria

4 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

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Data sourced from ClinicalTrials.gov (NCT00590759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.