PRESERVE-Zenith® Iliac Branch System Clinical Extended Study

Aorto-iliac Aneurysms Clinical Trial

Official title:

Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation With the ConnectSX™

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02571985
• Other study ID #: 05-625 CA-P1
• Status: No longer available
• Phase: N/A
• First received: September 28, 2015
• Last updated: March 3, 2017
• Start date: May 2012
• Est. completion date: October 2017

Study information

• Verified date: March 2017
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. completion date: October 2017
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aorto-iliac Aneurysms
• Iliac Aneurysm
• Iliac Aneurysms

Intervention

Device:
• Zenith® Branch Endovascular Graft-Iliac Bifurcation System
Zenith® Branch Endovascular Graft-Iliac Bifurcation (Branch Graft) with the ConnectSX™

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 Hospital	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University of Florida	Gainesville	Florida
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
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	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Mercy Hospital East Communities	St. Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Stanford University Medical School	Stanford	California
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

United States,