Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2017-01-06

Brief Summary

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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

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Detailed Description

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Conditions

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Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GORE CTAG Device

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.

Group Type EXPERIMENTAL

GORE CTAG Device

Intervention Type DEVICE

Endovascular aortic stent-graft

Interventions

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GORE CTAG Device

Endovascular aortic stent-graft

Intervention Type DEVICE

Other Intervention Names

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GORE Conformable TAG® Thoracic Endoprosthesis

Eligibility Criteria

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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\>

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No