PRESERVE-Zenith® Iliac Branch System Clinical Study

March 8, 2018 updated by: Cook Group Incorporated
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • VA Palo Alto HCS
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Christine E. Lynn Heart and Vascular Institute
      • Gainesville, Florida, United States, 32610
        • University of Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • 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
    • 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
    • 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
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device Implant
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.
Other Names:
  • Endovascular repair for aortoiliac or iliac aneurysm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients That Are Free From Patency-related Intervention
Time Frame: 6 Months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: W. Anthony Lee, MD, FACS, Christine E. Lynn Heart and Vascular Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 10, 2017

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria

September 23, 2010

First Posted (Estimate)

September 24, 2010

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-625-P1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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