Clinical Trial: PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
Brief Summary: The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.
Detailed Summary:
Sponsor: Cook
Current Primary Outcome: Number of patients with freedom from patency-related intervention defined as a secondary intervention to treat a > 60 % stenosis of the internal iliac artery associated with clinical symptoms. [ Time Frame: 6 months ]
Original Primary Outcome: Freedom from patency-related intervention [ Time Frame: 6 months ]
Current Secondary Outcome: Freedom from morbidity (i.e., morbidity index) [ Time Frame: 30 days ]
Original Secondary Outcome: Same as current
Information By: Cook
Dates:
Date Received: September 28, 2015
Date Started: April 2015
Date Completion: March 2020
Last Updated: March 3, 2017
Last Verified: March 2017