Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
|Abdominal Aortic Aneurysms Iliac Aneurysms Aorto-iliac Aneurysms||Device: Zenith(R) Low Profile AAA Endovascular Graft|
Access to an investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft|
- Patients With Major Adverse Events (MAE) [ Time Frame: 30-day ]MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.
- Patients With Device Failures [ Time Frame: 12-month ]
Device success at 12-month is defined as:
Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm.
|Study Start Date:||May 2008|
|Study Completion Date:||June 2016|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Treatment with Endovascular Graft
Device: Zenith(R) Low Profile AAA Endovascular Graft
The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833924
Show 27 Study Locations
|Principal Investigator:||Ronald Fairman, MD||University of Pennsylvania|