Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

Study Overview
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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

Official Title
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An Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aortic

Conditions
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Aneurysm

Intervention / Treatment
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* Device: GORE CTAG Device


Participation Criteria
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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:> 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>

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GORE CTAG Device<br>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. | Device: GORE CTAG Device<br>* Endovascular aortic stent-graft<br>* Other names: GORE Conformable TAG® Thoracic Endoprosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment |  | Treatment through 1 month post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment. |  | Treatment through 1 month post procedure | 
| Procedure Time (Minutes) | Total time in minutes required for surgical device implantation. | Initial Device Implant Procedure During Index Hospitalization | 
| Operative Blood Loss (mL) | Blood loss in mL during initial device implantation procedure | Initial Device Implant Procedure During Index Hospitalization | 
| Days of Convalescence Stay in an Intensive Care Unit | Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation | During the Index Hospitalization | 
| Total Length of Hospital Stay (Days) | Total days of hospital stay during the initial hospitalization for implantation of device | Total Duration of the Index Hospitalization | 
| Time in Days to Return to Normal Daily Activities | This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis. | Average time within one month window | 
| Procedural Survival | Subjects who survived the index procedure | Initial Device Implant Procedure During Index Hospitalization | 
| Intensive Care Unit (ICU) Stay | Subjects admitted to ICU during index hospitalization | Initial Device Implant Index Hospitalization |