Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of 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

Completed

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Key information

Conditions

Aortic Aneurysm, Thoracic Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

<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

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

Treatment and study plan

GORE TAG® Thoracic Endoprosthesis

Device

implant

Primary outcomes

Aneurysm Related Death

Time frame: 5 years

Freedom from aneurysm related mortality for TAG 05-02 subjects

Secondary outcomes

A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.

Time frame: 5 years

Proportion of subjects in TAG 05-02 with MAEs

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

A Clinical Evaluation of the GORE TAG Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms

Important dates

Study start: 2005
Primary completion: 2013
Study completion: 2013
First posted: Jan 11, 2008
Registry last updated: Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed