GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta

Study Overview
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Brief Summary
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The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.

Official Title
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Evaluation of the GORE TAG® Thoracic Endoprosthesis - 45 mm for the Primary Treatment of Aneurysms of the Descending Thoracic Aorta

Conditions
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Aortic Aneurysm, Thoracic

Intervention / Treatment
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* Device: GORE TAG® Thoracic Endoprosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair Fusiform (≥50 mm), or Saccular (no diameter criteria) All proximal and/or all distal landing zone inner diameters between 37-42 mm Diameter taper between proximal and distal landing zones and the ability to use devices of different diameters to compensate for the taper must be within device sizing guide specifications Proximal and distal landing zone length greater than 2.0 cm Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed Life expectancy > 2 years Subject is open surgical candidate defined as: Able to tolerate thoracotomy American Society of Anesthesiologists class I-IV (class V excluded) New York Heart Association class I-III or not applicable (class IV excluded) Male or infertile female Age greater than 21 years Able to comply with study protocol requirements, including follow-up Exclusion Criteria: Mycotic aneurysm Hemodynamically unstable aneurysm rupture Aortic dissection Planned occlusion of left carotid or celiac arteries Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date Myocardial infarction or stroke within 6 weeks of treatment Pre-treatment creatinine > 2.0 mg/dL Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome Participation in another drug or device study within 1 year of treatment History of drug abuse within 6 months of treatment

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GORE TAG® Thoracic Endoprosthesis<br>Gore 45mm TAG Thoracic Endograft Implantation | Device: GORE TAG® Thoracic Endoprosthesis<br>* Implant<br>* Other names: GORE TAG® Thoracic Endoprosthesis - 45 mm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment | Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149). | one year |