PRESERVE-Zenith® Iliac Branch System Clinical Study
|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: NCT01208415|
Recruitment Status : Completed
First Posted : September 24, 2010
Results First Posted : August 16, 2017
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aorto-iliac Aneurysms Iliac Aneurysms||Device: Endovascular repair for aortoiliac or iliac aneurysms.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PRESERVE-Zenith® Iliac Branch System Clinical Study|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 10, 2017|
|Experimental: Device Implant||
Device: Endovascular repair for aortoiliac or iliac aneurysms.
Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft.
Other Name: Endovascular repair for aortoiliac or iliac aneurysm.
- Patients That Are Free From Patency-related Intervention [ Time Frame: 6 Months ]Patency-related intervention is defined as: Secondary intervention to treat a > 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.
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): NCT01208415
|Principal Investigator:||W. Anthony Lee, MD, FACS||Christine E. Lynn Heart and Vascular Institute|