PRESERVE-Zenith® Iliac Branch System Clinical Study

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Cook Identifier:
First received: September 23, 2010
Last updated: September 28, 2015
Last verified: September 2015
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.

Condition Intervention
Aorto-iliac Aneurysms
Iliac Aneurysms
Device: Endovascular repair for aortoiliac or iliac aneurysms.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PRESERVE-Zenith® Iliac Branch System Clinical Study

Resource links provided by NLM:

Further study details as provided by Cook:

Primary Outcome Measures:
  • Freedom from patency-related intervention [ Time Frame: Procedure through 6-months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: May 2017
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Endovascular repair for aortoiliac or iliac aneurysm.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01208415

United States, California
VA Palo Alto HCS
Palo Alto, California, United States, 94304
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Florida
Christine E. Lynn Heart and Vascular Institute
Boca Raton, Florida, United States, 33431
University of Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Mercy Hospital East Communities
St. Louis, Missouri, United States, 63141
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Weill Cornell Medical Center
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Aurora St. Luke's Hospital
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Principal Investigator: W. Anthony Lee, MD, FACS Christine E. Lynn Heart and Vascular Institute
  More Information

Responsible Party: Cook Identifier: NCT01208415     History of Changes
Other Study ID Numbers: 05-625-P1 
Study First Received: September 23, 2010
Last Updated: September 28, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Zenith aortoiliac aneurysm
iliac aneurysm
endovascular graft
graft-iliac bifurcation
Vascular Diseases
Cardiovascular Diseases

Additional relevant MeSH terms:
Iliac Aneurysm
Cardiovascular Diseases
Vascular Diseases processed this record on May 05, 2016