TX2® Low Profile TAA Endovascular Graft

Study Overview
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Brief Summary
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The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.

Official Title
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Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Conditions
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Aortic Aneurysm, Penetrating Ulcer, Vascular Disease

Intervention / Treatment
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* Device: Zenith® TX2® Low Profile TAA Endovascular Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Descending thoracic aneurysm with diameter ≥ 5.0 cm Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter Exclusion Criteria: Less than 18 years of age Life expectancy less than 2 years Pregnant or breastfeeding or planning on becoming pregnant within 60 months Unwilling to comply with the follow-up schedule Inability or refusal to give informed consent Less than 30 days beyond primary endpoint for other investigative drug or device study

Ages Eligible for Study
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Minimum Age: 18 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: Arm 1<br>Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm) | Device: Zenith® TX2® Low Profile TAA Endovascular Graft<br>* Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair<br>* Other names: TEVAR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Major Adverse Events (MAE) | Major adverse event is defined as: All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation > 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room. | 30 days | 
| Patients With Device Failures | Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Aneurysm, Aneurysm, Vascular Prosthesis, Vascular Disease, Blood Vessel Prosthesis Implantation