PRESERVE-Zenith® Iliac Branch System Clinical Extended Study

NCT ID: NCT02571985

Last Updated: 2017-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Study Start Date

2012-05-31

Study Completion Date

2017-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aorto-iliac Aneurysms Iliac Aneurysms

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zenith® Branch Endovascular Graft-Iliac Bifurcation System

Zenith® Branch Endovascular Graft-Iliac Bifurcation (Branch Graft) with the ConnectSX™

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Endovascular repair for aortoiliac or iliac aneurysm

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

W. Anthony Lee, MD FACS

Role: PRINCIPAL_INVESTIGATOR

Christine E. Lynn Heart and Vascular Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA Palo Alto HCS

Palo Alto, California, United States

Site Status

Stanford University Medical School

Stanford, California, United States

Site Status

Christine E. Lynn Heart and Vascular Institute

Boca Raton, Florida, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

University of Massachusetts

Worcester, Massachusetts, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Mercy Hospital East Communities

St Louis, Missouri, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Weill Cornell Medical Center

New York, New York, United States

Site Status

University of North Carolina Hospital

Chapel Hill, North Carolina, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Aurora St. Luke's Hospital

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

05-625 CA-P1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Zenith® Fenestrated+ Clinical Study
NCT04875429 ACTIVE_NOT_RECRUITING NA
Sapphire II PRO US Clinical Study
NCT03052530 COMPLETED NA
DURABILITY™ Iliac Study
NCT01400919 COMPLETED NA
Zenith® Dissection Clinical Trial
NCT01568320 COMPLETED NA