PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study

Iliac Aneurysms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571907
• Other study ID #: 05-625 P2
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: November 4, 2020

Study information

• Verified date: June 2021
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 4, 2020
• Est. primary completion date: November 2015
• 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

• Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study

• Unwilling or unable to comply with the follow-up schedule

• Simultaneously participating in another investigative device or drug study

Related Conditions & MeSH terms

• Aneurysm
• Aortoiliac Aneurysms
• Iliac Aneurysm
• Iliac Aneurysms

Intervention

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

Locations

Country	Name	City	State
United States	Emory University Hospital	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	Cleveland Clinic Foundation	Cleveland	Ohio
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	University of Nebraska	Omaha	Nebraska
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 School	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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months
Secondary	Freedom from morbidity (i.e., morbidity index)	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).	30 days