Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
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|ClinicalTrials.gov Identifier: NCT00833924|
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : January 29, 2016
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysms Iliac Aneurysms Aorto-iliac Aneurysms||Device: Zenith(R) Low Profile AAA Endovascular Graft||Not Applicable|
Expanded Access : An investigational treatment associated with this study is no longer 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|
|Actual Primary Completion Date :||October 2011|
|Actual 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.
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): NCT00833924
|Principal Investigator:||Ronald Fairman, MD||University of Pennsylvania|