Zenith® Low Profile AAA Endovascular Graft

NCT ID: NCT02557659

Last Updated: 2018-03-12

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

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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This extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data.

Detailed Description

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Conditions

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Abdominal Aortic Aneurysms Iliac Aneurysms Aorto-iliac Aneurysms

Interventions

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Zenith Low Profile AAA Endovascular Graft

Treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

•Subject has at least one of the following

* Aortic or aortoiliac aneurysm
* Iliac aneurysm
* Aneurysm with a history of growth

Exclusion Criteria

* Less than 18 years of age
* Inability or refusal to give informed consent
* Life expectancy less than 2 years
* Pregnant of breastfeeding or planning on becoming pregnant with 60 months
* Unwilling to comply with the follow-up schedule
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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Ronald Fairman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of California San Francisco-VA

San Francisco, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Stanford University Medical School

Stanford, California, United States

Site Status

Yale New Haven School of Medicine

New Haven, Connecticut, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Massachusetss General Hospital

Boston, Massachusetts, United States

Site Status

University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status

Mercy Hospital

St Louis, Missouri, United States

Site Status

Morristown Memorial Hospital

Morristown, New Jersey, United States

Site Status

New York University - Langone Medical Center

New York, New York, United States

Site Status

New York Presbyterian Hospital - Cornell

New York, New York, United States

Site Status

New York Presbyterian - Columbia

New York, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Ohio Health Research Institute

Columbus, Ohio, 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 Washington-Harborview Medical Center

Seattle, Washington, United States

Site Status

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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08-013 CA

Identifier Type: -

Identifier Source: org_study_id

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