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Home » Clinical Trials » Aneurysm

Clinical Trial Details

Overview

Research Study Summary

A clinical trial to evaluate treatments using Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm) for patients with Aortic Aneurysm, Penetrating Ulcer or Vascular Disease

Research Study Title

Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Purpose

The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.

To Learn more
Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Cook

Duration

39 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • Descending thoracic aneurysm with diameter ≥ 5.0 cm

  • Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year

  • Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

  • Less than 18 years of age

  • Life expectancy less than 2 years

  • Pregnant or breastfeeding or planning on becoming pregnant within 60 months

  • Unwilling to comply with the follow-up schedule

  • Inability or refusal to give informed consent

  • Less than 30 days beyond primary endpoint for other investigative drug or device study

Site Locations (14)

Country State City Zip Facility and Contact
United States Florida Tampa 33606 University of South Florida
Stephenie Yachanyk, RN
813-259-0921
syapchan@health.usf.edu
United States Georgia Atlanta 30322 Emory University
Ravi Veeraswamy, MD
404-778-4465
ravi_veeraswamy@emoryhealthcare.org
United States Indiana Indianapolis 46250 Indiana Heart Hospital
Gregory Dedinsky, MD
317-621-8500
gdedinsky@ecommunity.com
United States Michigan Ann Arbor 48109 University of Michigan
Himanshu Patel, MD
734-936-4478
hjpatel@med.umich.edu
United States Minnesota Rochester 55905 Mayo Clinic Rochester
Gustavo Oderich, MD
507-225-7208
oderich.gustavo@mayo.edu
United States Missouri St. Louis 63110 Barnes-Jewish Hospital
Patrick Geraghty, MD
314-362-6490
geraghty@wudosis.wustl.edu
United States New Hampshire Lebanon 03756 Dartmouth Hitchcock Medical Center
Mark Fillinger, MD
603-650-8677
mark.f.fillinger@hitchcock.org
United States New Jersey Camden 08103 Cooper University Hospital
Francis Caputo, MD
856-342-3113
caputo-francis@cooperhealth.edu
United States New Jersey Hackensack 07601 Hackensack University Medical Center
Susan Mathus, BSN, RN, CCRC
551-996-5722
smathus@hackensackumc.org
United States New York New York 10029 Mount Sinai Hospital
Sharif Ellozy, MD
212-241-3738
sharif.ellozy@mountsinai.org
United States North Carolina Chapel Hill 27599 University of North Carolina
Mark Farber, MD
919-966-3391
farberm@med.unc.edu
United States North Carolina Durham 27710 Duke University Medical Center
Chad Hughes, MD
919-668-0903
gchag.hughes@duke.edu
United States Ohio Columbus 43210 Ohio State University
Jean Starr, MD
614-293-8536
jean.starr@osumc.edu
United States Pennsylvania Philadelphia 19104 Hospital of the University of Pennsylvania
Grace Wang, MD
215-614-0308
grace.wang@uphs.upenn.edu

Contact

Jennifer Gilmore
765-463-7537

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01151020

Date Last Changed: February 3, 2014

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