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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

116 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 (22)

Country State City Zip Facility and Contact
United States California San Francisco 94115 Kaiser Permanente
Cristina Casias
415-833-2247
cristina.casias@kp.org
United States Colorado Aurora 80045 University of Denver Colorado
Brett Reece, MD
303-724-2757
Brett.reece@ucdenver.edu
United States Florida Gainesville 32610 University of Florida
Nancy Hanson
352-273-5479
nancy.hanson@surgery.ufl.edu
United States Florida Tampa 33601 Tampa General Hospital
Stephanie Yapchanyk
813-844-7000
syapchan@health.usf.edu
United States Illinois Peoria 61614 Heart Care Midwest
Marsha Pierson
309-691-4410
marsha.a.pierson@heartcaremw.com
United States Iowa West Des Moines 50266 Iowa Heart Center
Grasheila Wilson, RN,BSN
515-633-3847
gwilson@iowaheart.com
United States Massachusetts Worcester 01655 University of Massachusetts
Shauneen Valliere, RN, MSN
508-865-1767
shauneen.valliere@umassmed.edu
United States Michigan Ann Arbor 48109 University of Michigan Hospital
Craig Urwin
734-936-9664
craijose@med.umich.edu
United States New Hampshire Lebanon 03756 Dartmouth Hitchcock Medical Center
Sharon Segel
603-650-6379
sharon.m.segel@hitchcock.org
United States New Jersey Camden 08103 Cooper University Hospital
Jonelle O'Shea, RN, MSN
856-298-3334
Oshea-Jonelle@CooperHealth.edu
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
Roger Swayze
718-920-2221
rswayze@montefiore.org
United States New York Rochester 14642 Strong Memorial Hospital
Jennifer Ellis, MD
585-275-6772
jenniferL_ellis@urmc.rochester.edu
United States North Carolina Chapel Hill 27599 University of North Carolina
Dianne Glover, RN
919-843-1278
dglover@med.unc.edu
United States Pennsylvania Philadelphia 19104 Hospital of the University of Pennsylvania
Danh Vuong
215-662-4223
danh.vuong@uphs.upenn.edu
United States Pennsylvania Pittsburgh 15212 Allegheny General Hospital
Sheila Bernardini, RN
412-359-3281
sbernard@wpahs.org
United States Texas Dallas 75208 DFW Vascular Group
Connie Cross, CCRP
214-946-5165
ccross@dfwvascular.com
United States Texas Dallas 75226 Baylor University Medical Center at Dallas
Merielle Boatman
214-820-2273
merielle.boatman@baylorhealth.edu
United States Texas Plano 75093 The Heart Hospital Baylor Plano
Mary Dettaas, RN, CCRC
469-814-4712
maryden@baylorhealth.edu
United States Virginia Charlottsville 22908 University of Virginia Medical Center
Kimberly Gahring
434-243-0315
rag3x@virginia.edu
United States Washington Seattle 98104 Harborview Medical Center
Billi Tatum, RN, CCRC
206-744-3369
btatum@uw.edu
Canada Ontario London N6A 5W9 London Health Sciences Centre
Tom Forbes, MD
Tom.forbes@lhsc.on.ca

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: NCT00813358

Date Last Changed: March 6, 2014

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