PRESERVE-Zenith® Iliac Branch System Clinical Study

Aorto-iliac Aneurysms Clinical Trial

Official title:

PRESERVE-Zenith® Iliac Branch System Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208415
• Other study ID #: 05-625-P1
• Status: Completed
• Phase: N/A
• First received: September 23, 2010
• Last updated: March 8, 2018
• Start date: January 2011
• Est. completion date: October 10, 2017

Study information

• Verified date: September 2017
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 10, 2017
• Est. primary completion date: October 2012
• 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
• Aorto-iliac Aneurysms
• Iliac Aneurysm
• Iliac Aneurysms

Intervention

Device:
• Endovascular repair for aortoiliac or iliac aneurysms.
Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ 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	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	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 Group Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients That Are Free From Patency-related Intervention	Patency-related intervention is defined as: Secondary intervention to treat a > 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.	6 Months