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

Not Applicable

Completed

Conditions: Aortoiliac Aneurysms
Iliac Aneurysms

Interventions: Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,
Device: Atrium iCAST™
Device: Zenith® Flex AAA Endovascular Graft

Registration Number: NCT02571907

Lead Sponsor: Cook Research Incorporated

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zenith® Branch Endovascular Graft-Iliac Bifurcation	Zenith® Flex AAA Endovascular Graft	Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
Zenith® Branch Endovascular Graft-Iliac Bifurcation	Atrium iCAST™	Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
Zenith® Branch Endovascular Graft-Iliac Bifurcation	Zenith® Branch Endovascular Graft-Iliac Bifurcation,	Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Freedom from morbidity (i.e., morbidity index)	30 days	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).

Trial Locations

Locations (28): Christine E. Lynn Heart and Vascular Institute
🇺🇸
Boca Raton, Florida, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
St. Anthony's Medical Center
🇺🇸
Rockford, Illinois, United States
University of Massachusetts
🇺🇸
Worcester, Massachusetts, United States
Weill Cornell Medical Center
🇺🇸
New York, New York, United States
UT Southwestern
🇺🇸
Dallas, Texas, United States
Stanford University Medical School
🇺🇸
Stanford, California, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Mayo Foundation for Medical Education and Research
🇺🇸
Phoenix, Arizona, United States
South Florida Medical Imaging
🇺🇸
Fort Lauderdale, Florida, United States
VA Palo Alto HCS
🇺🇸
Palo Alto, California, United States
Methodist Hospital of Indiana
🇺🇸
Indianapolis, Indiana, United States
University of Kentucky Hospital
🇺🇸
Lexington, Kentucky, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
Mercy Hospital East Communities
🇺🇸
Saint Louis, Missouri, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Aurora St. Luke's Hospital
🇺🇸
Milwaukee, Wisconsin, United States
Dartmouth Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
University of North Carolina
🇺🇸
Chapel Hill, North Carolina, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
University of Florida
🇺🇸
Gainesville, Florida, United States
University of Nebraska
🇺🇸
Omaha, Nebraska, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States