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PRESERVE-Zenith® Iliac Branch System Clinical Extended Study

Conditions
Aorto-iliac Aneurysms
Iliac Aneurysms
Registration Number
NCT02571985
Lead Sponsor
Cook Group Incorporated
Brief Summary

The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation System. This system is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms

Detailed Description

Not available

Recruitment & Eligibility

Status
NO_LONGER_AVAILABLE
Sex
All
Target Recruitment
Not specified
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
  • Unsuitable arterial anatomy

Study & Design

Study Type
EXPANDED_ACCESS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (19)

Christine E. Lynn Heart and Vascular Institute

🇺🇸

Boca Raton, Florida, United States

Emory University

🇺🇸

Atlanta, Georgia, United States

Allegheny General Hospital

🇺🇸

Pittsburgh, Pennsylvania, United States

Hospital of the University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

🇺🇸

Pittsburgh, Pennsylvania, United States

University of Florida

🇺🇸

Gainesville, Florida, United States

University of Virginia

🇺🇸

Charlottesville, Virginia, United States

VA Palo Alto HCS

🇺🇸

Palo Alto, California, United States

Stanford University Medical School

🇺🇸

Stanford, California, United States

University of Massachusetts

🇺🇸

Worcester, Massachusetts, United States

William Beaumont Hospital

🇺🇸

Royal Oak, Michigan, United States

Mercy Hospital East Communities

🇺🇸

St. Louis, Missouri, United States

Dartmouth Hitchcock Medical Center

🇺🇸

Lebanon, New Hampshire, United States

Weill Cornell Medical Center

🇺🇸

New York, New York, United States

Columbia University Medical Center

🇺🇸

New York, New York, United States

Washington University School of Medicine

🇺🇸

St. Louis, Missouri, United States

University of North Carolina Hospital

🇺🇸

Chapel Hill, North Carolina, United States

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

Aurora St. Luke's Hospital

🇺🇸

Milwaukee, Wisconsin, United States

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