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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
GORE TAG® Thoracic Endoprosthesis	GORE TAG® Thoracic Endoprosthesis	Gore 45mm TAG Thoracic Endograft Implantation

Primary Outcome Measures

Name	Time	Method
Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment	one year	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).

Secondary Outcome Measures