PRESERVE-Zenith® Iliac Branch System Clinical Study

NCT ID: NCT01208415

Last Updated: 2018-04-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2017-10-10

Brief Summary

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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.

Detailed Description

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Conditions

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Aorto-iliac Aneurysms Iliac Aneurysms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Device Implant

Group Type EXPERIMENTAL

Endovascular repair for aortoiliac or iliac aneurysms.

Intervention Type DEVICE

Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Endovascular repair for aortoiliac or iliac aneurysm.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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W. Anthony Lee, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Christine E. Lynn Heart and Vascular Institute

Locations

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VA Palo Alto HCS

Palo Alto, California, United States

Site Status

Stanford University Medical Center

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

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

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United States

Other Identifiers

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05-625-P1

Identifier Type: -

Identifier Source: org_study_id

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