TX2® Low Profile TAA Endovascular Graft (TX2® LP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01151020|
Recruitment Status : Active, not recruiting
First Posted : June 25, 2010
Results First Posted : February 29, 2016
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment|
|Aortic Aneurysm Penetrating Ulcer Vascular Disease||Device: Zenith® TX2® Low Profile TAA Endovascular Graft|
An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study|
|Study Start Date :||March 2010|
|Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||December 2019|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151020
Show 33 Study Locations
|Principal Investigator:||Karl Illig, MD||University of South Florida|