Status:
COMPLETED
Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Aneurysm
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (DTA) \> Primary Hypothesis: The proportio...
Eligibility Criteria
Inclusion
- \>
- 1\. Presence of DTA aneurysm deemed to warrant surgical repair \>
- Fusiform (≥50 mm), or \>
- Saccular (no diameter criteria)\> 2. Subject is \> 21 years of age\> 3. Proximal and distal landing zone length ≥ 2.0 cm \>
- Landing zones must be in native aorta\>
- Landing zone may include left subclavian artery, if necessary\> 4. All proximal and distal landing zone inner diameters are between 16-42 mm\>
- Diameter assessed by flow lumen and thrombus, if present; calcium excluded\> 5. Life expectancy \> 2 years\> 6. Able to tolerate thoracotomy \> 7. Male or infertile female\> 8. Able to comply with protocol requirements including following-up\> 9. Signed informed consent\>
Exclusion
- \>
- Differing proximal and distal neck diameters (aortic taper) outside the intended aortic diameter requirements (sizing guide) for a single endoprosthesis diameter and the inability to use devices of different diameters (in adherence to the sizing guide) to compensate for the taper\>
- Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access\>
- Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)\>
- Mycotic aneurysm\>
- Hemodynamically unstable aneurysm rupture\>
- Aortic dissection\>
- Planned coverage of left carotid or celiac arteries with the CTAG Device\>
- Planned concomitant surgical procedure (other than left subclavian transposition and wireless sac pressure monitoring), or major surgery within 30 days of treatment date\>
- Known degenerative connective tissue disease, e.g. Marfan or Ehler-Danlos Syndrome\>
- Known history of drug abuse\>
- ASA risk classification = V (moribund patient not expected to live 24 hours with or without operation)\>
- NYHA class IV \>
- Participating in another investigational device or drug study within 1 year of treatment\>
- Subject has known sensitivities or allergies to the device materials\>
- Subject has a systemic infection and may be at increased risk of endovascular graft infection\>
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2017
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00874250
Start Date
June 1 2009
End Date
January 6 2017
Last Update
August 25 2017
Active Locations (1)
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1
University of Alabama Medical Center
Birmingham, Alabama, United States, 35294