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

Launched by W.L.GORE & ASSOCIATES · Feb 5, 2008

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair
• • Fusiform (≥50 mm), or
• • Saccular (no diameter criteria)
• • 2. 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
• • 3. Proximal and distal landing zone length greater than 2.0 cm
• • Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed
• • 4. Life expectancy \> 2 years
• 5. 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)
• • 6. Male or infertile female
• • 7. Age greater than 21 years
• • 8. Able to comply with study protocol requirements, including follow-up
• Exclusion Criteria:
• • 1. Mycotic aneurysm
• • 2. Hemodynamically unstable aneurysm rupture
• • 3. Aortic dissection
• • 4. Planned occlusion of left carotid or celiac arteries
• • 5. Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date
• • 6. Myocardial infarction or stroke within 6 weeks of treatment
• • 7. Pre-treatment creatinine \> 2.0 mg/dL
• • 8. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
• • 9. Participation in another drug or device study within 1 year of treatment
• • 10. History of drug abuse within 6 months of treatment