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Clinical Trial Details

Overview

Research Study Summary

A Phase 4 clinical study for patients with Thoracic Aortic Aneurysms

Research Study Title

Descending Thoracic Aortic Aneurysm Endovascular Repair Post-approval Study (THRIVE)

Purpose

The purpose of this study is to evaluate the long-term safety and effectiveness of the Talent Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following U.S. market approval.

To Learn more
Phase

4

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Medtronic Endovascular

Duration

121 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria: appropriate anatomy for elective repair of the descending thoracic aortic aneurysm

  • iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and or accessories

  • non-aneurysmal aortic diameter in the range of 18-42mm; and

  • non-aneurysmal aortic proximal and distal neck lengths equal to or greater than 20mm

  • subject has a Descending Fusiform Thoracic Aneurysm = to or greater than 5cm in diameter OR is = to or greater than 2 times the diameter of the non-aneurysmal thoracic aorta and/or saccular aneurysms/penetrating ulcers

  • Signed patient informed consent

Exclusion Criteria:

  • Less than 18 yrs old

  • pregnant

  • unable to comply w/follow-up

  • participating in other drug or device trials;

  • Subject has a co-morbidity causing expected survival to be less than 1 year

Site Locations (23)

Country State City Zip Facility and Contact
United States California Los Angeles 90048 Cedars Sinai Medical Center
Ali Khoynezhad, MD
310-423-3851
khoynezhada@cshs.org

Ali Khoynezhad, MD
Principal Investigator
United States California Torrance 90502 Harbor-UCLA
Rodney A White, MD
310-222-2704
rawhite@ucla.edu

Rodney A. White, MD
Principal Investigator
United States District of Columbia Washington, DC 20010 Washington Hospital D.C.
Frederick P. Beavers, MD
202-877-8050
frederick.p.beavers@medstar.net

Fred Beavers, MD
Principal Investigator
United States Florida Gainesville 32610 U Florida at Shands Hospital
Robert Feezor, MD
352-273-7020
feezor@surgery.ufl.edu

Robert Feezor, MD
Principal Investigator
United States Florida Kissimmee 34741 Osceola Regional Med Ctr
Matthew Campbell, MD
407-846-0090
mcampbell@heartsurgery-csa.com

Matthew Campbell, MD
Principal Investigator
United States Georgia Atlanta 30322 Emory University
Joseph Ricotta, MD
404-778-5451
joseph.ricotta@emoryhealthcare.org

Karthikeshwar Kasirajan, MD
Principal Investigator
United States Illinois Chicago 60611 Northwestern MH
Heron Rodriguez, MD
312-695-4740
meskanda@nmh.org

Heron Rodriguez, MD
Principal Investigator
United States Illinois Springfield 62702 Southern Illinois University
Kim Hodgson, MD
217-545-8856
khodgson@siumed.edu

Kim Hodgson, MD
Principal Investigator
United States Massachusetts Boston 02115 Brigham & Women's Hospital
Edwin C. Gravereaux, MD
857-307-1920
egravereaux@partners.org

Edwin C. Gravereaux, MD
Principal Investigator
United States New York Albany 12208 Albany Medical Center
Manish Mehta, MD
518-218-0148
mehtam@albanyvascular.com

Manish Mehta, MD
Principal Investigator
United States New York Lake Success 11042 Northshore University Hospital
Kambhampaty Krishnasastry, MD
516-562-4821
kkrishna@nshs.edu

Kambhampaty Krishnasastry, MD
Principal Investigator
United States North Carolina Durham 27710 Duke University Medical Center
Charles Hughes, MD
919-668-0903
hughe007@mc.duke.edu

Charles Hughes, MD
Principal Investigator
United States Ohio Toledo 43615 University of Toledo Med Ctr
Munier Nazzal, MD
419-383-3576
munier.nazzal@utoledo.edu

Munier Nazzal, MD
Principal Investigator
United States Pennsylvania Wormleysburg 17043 Pinnacle Health
Brijeshwar Maini, MD
717-731-0101
brij.maini@moffittheart.com

Brijeshwar Maini, MD
Principal Investigator
United States Tennessee Chattanooga 37404 Memorial Hospital
Clifton Reade, MD
423-624-5200
creade@actsurgeons.com

Clifton Reade, MD
Principal Investigator

Mark Fugate, MD
Principal Investigator
United States Tennessee Memphis 38120 Baptist Memorial Hospital
Edward Garrett, MD
901-747-3066
egarrettmd@cvsclinic.com

Edward Garrett, MD
Principal Investigator
United States Tennessee Powell 37849 Tennova Physicians Regional Medical Center
George Pliagas, Md
865-938-8121
gpliagas@premiersurgical.com

George Pliagas, MD
Principal Investigator
United States Texas Houston 77030 The Methodist Hospital
Jean Bismuth, MD
713-441-5200
jbismuth@tmhs.org

Jean Bismuth, MD
Principal Investigator
United States Texas Houston 77030 Baylor College of Medicine
Joseph S. Coselli, MD
832-355-9910
jcoselli@bcm.edu

Joseph S. Coselli, MD
Principal Investigator
United States Texas Plano 38120 The Heart Hospital/Baylor Plano
Dennis Gable, MD
972-665-9100
DennisG@baylorhealth.edu

Dennis Gable, MD
Principal Investigator
United States Virginia Norfolk 23507 Sentara Norfolk General Vascular & Transplant Specialists
Jean Panneton, MD
757-622-2649
jmpanneb@sentara.com

Jean Panneton, MD
Principal Investigator
United States Washington Seattle 98195 University of Washington
Mark H. Meissner, MD
206-221-7047
meissner@u.washington.edu

Mark H. Meissner, MD
Principal Investigator
United States Washington Spokane 99204 Providence Sacred Heart
Braden Batkoff, MD
509-455-8820
bbatkoff@spokanecardiology.com

Braden Batkoff, MD
Principal Investigator

Contact

P J Belmont
707-591-2520

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: NCT00805948

Date Last Changed: January 7, 2014

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