PRESERVE-Zenith® Iliac Branch System Clinical Extended Study

• Conditions: Aorto-iliac Aneurysms; Iliac Aneurysms

• Registration Number: NCT02571985
• Lead Sponsor: Cook Group Incorporated

Brief Summary

The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation System. This system is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2013-04
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-03
• Last Update Posted: 2017-03-07
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• An aortioiliac or iliac aneurysm
• An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery

Exclusion Criteria

• Less than 18 years of age
• Inability or refusal to give informed consent
• Disease considerations that would compromise patient safety or study outcomes
• Unsuitable arterial anatomy

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (19)

VA Palo Alto HCS; 🇺🇸 Palo Alto, California, United States

Stanford University Medical School; 🇺🇸 Stanford, California, United States

Christine E. Lynn Heart and Vascular Institute; 🇺🇸 Boca Raton, Florida, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

Mercy Hospital East Communities; 🇺🇸 St. Louis, Missouri, United States

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