Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
|ClinicalTrials.gov Identifier: NCT00833924|
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : January 29, 2016
Last Update Posted : February 6, 2017
|Condition or disease||Intervention/treatment|
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft|
|Study Start Date :||May 2008|
|Primary Completion Date :||October 2011|
|Study Completion Date :||June 2016|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833924
Show 27 Study Locations
|Principal Investigator:||Ronald Fairman, MD||University of Pennsylvania|