Zenith TX2® Post-market Approval Study

NCT ID: NCT00813358

Last Updated: 2021-06-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-10

Study Completion Date

2020-03-23

Brief Summary

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The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.

Detailed Description

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Conditions

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Descending Thoracic Aortic Aneurysm

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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Endovascular repair

treatment

Group Type EXPERIMENTAL

Zenith TX2® TAA Endovascular Graft

Intervention Type DEVICE

Endovascular treatment with the study device

Interventions

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Zenith TX2® TAA Endovascular Graft

Endovascular treatment with the study device

Intervention Type DEVICE

Other Intervention Names

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TEVAR

Eligibility Criteria

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Inclusion Criteria

* Descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or
* Descending thoracic aortic aneurysm with a history of growth greater than or equal to 0.5 cm within the previous 12 months; or
* Descending thoracic aortic degenerative or atherosclerotic ulcers greater than or equal to 10 mm in depth and 20 mm in diameter

Exclusion Criteria

* Age less than 18 years
* Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years)
* Pregnant, breast-feeding, or planning on becoming pregnant within 24 months
* Unwilling or unable to comply with the follow-up schedule
* Inability or refusal to give informed consent
* Simultaneously participating in another investigative device or drug study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Research Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaiser Permanente

San Francisco, California, United States

Site Status

University of Denver Colorado

Aurora, Colorado, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Tampa General Hospital

Tampa, Florida, United States

Site Status

Heart Care Midwest

Peoria, Illinois, United States

Site Status

Iowa Heart Center

West Des Moines, Iowa, United States

Site Status

University of Massachusetts

Worcester, Massachusetts, United States

Site Status

University of Michigan Hospital

Ann Arbor, Michigan, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Cooper University Hospital

Camden, New Jersey, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

New York Hospital of Queens

Flushing, New York, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

New York University

New York, New York, United States

Site Status

Strong Memorial Hospital

Rochester, New York, United States

Site Status

Montefiore Medical Center

The Bronx, 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

DFW Vascular Group

Dallas, Texas, United States

Site Status

Baylor University Medical Center at Dallas

Dallas, Texas, United States

Site Status

The Heart Hospital Baylor Plano

Plano, Texas, United States

Site Status

University of Virginia Medical Center

Charlottesville, Virginia, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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United States Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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370024, 2PAS

Identifier Type: -

Identifier Source: secondary_id

08-005

Identifier Type: -

Identifier Source: org_study_id

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