Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

W.L. Gore & Associates

Status: Completed

Conditions: Aneurysm

Treatments: Device: GORE CTAG Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00874250

TAG 08-03

Details and patient eligibility

About

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 proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95, which represents the proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis

Enrollment: 51 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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>

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

GORE CTAG Device

Experimental group

Description:

The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.

Treatment:

Device: GORE CTAG Device