Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

NCT ID: NCT00833924

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2016-06-30

Brief Summary

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The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.

Detailed Description

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Conditions

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Abdominal Aortic Aneurysms Iliac Aneurysms Aorto-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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1

Treatment with Endovascular Graft

Group Type OTHER

Zenith(R) Low Profile AAA Endovascular Graft

Intervention Type DEVICE

The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.

Interventions

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Zenith(R) Low Profile AAA Endovascular Graft

The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular 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

* Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size
* Vessels suitable for endovascular access and aneurysm repair

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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Ronald Fairman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC

San Francisco, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

Yale New Haven School of Med., Dept. of Vascular Surgery

New Haven, Connecticut, United States

Site Status

University of Florida, Vascular Surgery

Gainesville, Florida, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Michigan Hospital

Ann Arbor, Michigan, United States

Site Status

Spectrum Health Butterworth

Grand Rapids, 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 Hospital

New York, New York, United States

Site Status

New York Presbyterian Hospital - Cornell

New York, New York, United States

Site Status

University of Rochester, Strong Memorial Hospital

Rochester, 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

Fairfax Inova Hospital

Falls Church, Virginia, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Queen Mary Hospital

Hong Kong, , China

Site Status

St. Franziskus Hospital

Münster, , Germany

Site Status

CELT Hospital

Moscow, , Russia

Site Status

Malmo University Hospital

Malmo, , Sweden

Site Status

Countries

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United States China Germany Russia Sweden

Other Identifiers

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370016

Identifier Type: -

Identifier Source: secondary_id

08-013

Identifier Type: -

Identifier Source: org_study_id

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