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

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

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.

Study Overview

• Status: Completed
• Conditions: Iliac Aneurysms; Aortoiliac Aneurysms
• Intervention / Treatment: Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,; Device: Atrium iCAST™; Device: Zenith® Flex AAA Endovascular Graft

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Foundation for Medical Education and Research
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto HCS
    • Stanford, California, United States, 94305
      • Stanford University Medical School
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Christine E. Lynn Heart and Vascular Institute
    • Fort Lauderdale, Florida, United States, 33308
      • South Florida Medical Imaging
    • Gainesville, Florida, United States, 32610
      • University of Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Rockford, Illinois, United States, 61108
      • St. Anthony's Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Methodist Hospital of Indiana
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Hospital
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital East Communities
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • University of Nebraska
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Weill Cornell Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75235
      • UT Southwestern
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,; Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.; Other Names: Branch Graft; Device: Atrium iCAST™; Implantation of Atrium iCAST; Device: Zenith® Flex AAA Endovascular Graft; Implantation of the Zenith Flex Endovascular Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cook Research Incorporated
• Investigators: Principal Investigator: W. Anthony Lee, MD FACS, Christine E. Lynn Heart and Vascular Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 4, 2020

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: October 6, 2015
• First Posted (Estimated): October 8, 2015

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Vascular Diseases; Cardiovascular Diseases; Aneurysm; Branch; Zenith aortoiliac aneurysm; Iliac aneurysm; Connections; Endovascular graft; Graft-iliac bifurcation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aneurysm; Iliac Aneurysm
• Other Study ID Numbers: 05-625 P2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes