Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT00874250
Eligibility Criteria:
Inclusion Criteria:\>
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 Criteria:\>
1. 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\>
2. Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access\>
3. Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)\>
4. Mycotic aneurysm\>
5. Hemodynamically unstable aneurysm rupture\>
6. Aortic dissection\>
7. Planned coverage of left carotid or celiac arteries with the CTAG Device\>
8. Planned concomitant surgical procedure (other than left subclavian transposition and wireless sac pressure monitoring), or major surgery within 30 days of treatment date\>
9. Known degenerative connective tissue disease, e.g. Marfan or Ehler-Danlos Syndrome\>
10. Known history of drug abuse\>
11. ASA risk classification = V (moribund patient not expected to live 24 hours with or without operation)\>
12. NYHA class IV \>
13. Participating in another investigational device or drug study within 1 year of treatment\>
14. Subject has known sensitivities or allergies to the device materials\>
15. Subject has a systemic infection and may be at increased risk of endovascular graft infection\>
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00874250
Study Brief:
Protocol Section:
NCT00874250