TX2® Low Profile TAA Endovascular Graft (TX2® LP)
|Aortic Aneurysm Penetrating Ulcer Vascular Disease||Device: Zenith® TX2® Low Profile TAA Endovascular Graft|
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|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study|
- Patients With Major Adverse Events (MAE) [ Time Frame: 30 days ]
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.
- Patients With Device Failures [ Time Frame: 12 months ]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.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||December 2019|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)
Device: Zenith® TX2® Low Profile TAA Endovascular Graft
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
Please refer to this study by its ClinicalTrials.gov identifier: NCT01151020
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|Principal Investigator:||Karl Illig, MD||University of South Florida|