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 ]

Secondary intervention to treat a > 60% stenosis of the internal iliac artery associated with clinical symptoms


Current Secondary Outcome: Freedom from morbidity (i.e., morbidity index) [ Time Frame: 30 days ]

Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular).


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