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Home » Clinical Trials » Aneurysm

Clinical Trial Details

Overview

Research Study Summary

A clinical research study of Zenith TX2® TAA Endovascular Graft for the treatment of Descending Thoracic Aortic Aneurysm

Research Study Title

Zenith TX2® TAA Endovascular Graft Post-approval Study

Purpose

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.

To Learn more
Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Cook

Duration

125 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

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

Site Locations (20)

Country State City Zip Facility and Contact
United States California San Francisco 94115 Kaiser Permanente
United States Colorado Aurora 80045 University of Denver Colorado
United States Florida Gainesville 32610 University of Florida
United States Florida Tampa 33601 Tampa General Hospital
United States Iowa West Des Moines 50266 Iowa Heart Center
United States Massachusetts Worcester 01655 University of Massachusetts
United States Michigan Ann Arbor 48109 University of Michigan Hospital
United States New Hampshire Lebanon 03756 Dartmouth Hitchcock Medical Center
United States New Jersey Camden 08103 Cooper University Hospital
United States New Jersey Hackensack 07601 Hackensack University Medical Center
Susan Mathus
551-996-5722
smathus@hackensackUMC.org
United States New York Bronx 10467 Montefiore Medical Center
United States New York Rochester 14642 Strong Memorial Hospital
United States North Carolina Chapel Hill 27599 University of North Carolina
United States Pennsylvania Philadelphia 19104 Hospital of the University of Pennsylvania
United States Pennsylvania Pittsburgh 15212 Allegheny General Hospital
United States Texas Dallas 75226 Baylor University Medical Center at Dallas
United States Texas Dallas 75208 DFW Vascular Group
United States Texas Plano 75093 The Heart Hospital Baylor Plano
United States Virginia Charlottsville 22908 University of Virginia Medical Center
United States Washington Seattle 98104 Harborview Medical Center

Contact

Jennifer Gilmore
765-463-7537
E-mail:

NCT ID: NCT00813358

Date Last Changed: September 10, 2014

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