PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation

Iliac Aneurysms Clinical Trial

Official title:

Clinical Study to Collect Confirmatory Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02475798
• Other study ID #: 05-625 CA-P2
• Status: No longer available

Study information

• Verified date: December 2020
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

The purpose of this extended study is to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and iliac aneurysms.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• An aortoiliac or iliac aneurysm of appropriate size
• Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac 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

Related Conditions & MeSH terms

• Aneurysm
• Aortoiliac Aneurysms
• Iliac Aneurysm
• Iliac Aneurysms

Intervention

Device:
• Zenith® Branch Endovascular Graft-Iliac Bifurcation,
Implantation of the following devices: Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Atrium iCAST™, and the Zenith® Flex AAA Endovascular Graft.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Christine E. Lynn Heart and Vascular Institute	Boca Raton	Florida
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	UT Southwestern	Dallas	Texas
United States	South Florida Medical Imaging	Fort Lauderdale	Florida
United States	University of Florida	Gainesville	Florida
United States	Methodist Hospital of Indiana	Indianapolis	Indiana
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Kentucky Hospital	Lexington	Kentucky
United States	Aurora St. Luke's Hospital	Milwaukee	Wisconsin
United States	Columbia University Medical Center	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	VA Palo Alto HCS	Palo Alto	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Foundation for Medical Education and Research	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Anthony's Medical Center	Rockford	Illinois
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Mercy Hospital East Communities	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Stanford University Medical Center	Stanford	California
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Country where clinical trial is conducted

United States,