Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)

This study is currently recruiting participants.
Verified January 2014 by Medtronic Endovascular
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00805948
First received: December 8, 2008
Last updated: January 7, 2014
Last verified: January 2014
  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.


Condition Intervention Phase
Thoracic Aortic Aneurysms
Device: Talent Thoracic Stent Graft System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Descending Thoracic Aortic Aneurysm Endovascular Repair Post-approval Study (THRIVE)

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Freedom from aneurysm-related mortality at 5 years [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 256
Study Start Date: January 2009
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Group
Patients diagnosed with a descending thoracic aortic aneurysm are considered candidates for the endovascular repair. The Talent Thoracic Stent Graft System is compressed and pre-loaded into the delivery system,which is inserted endoluminally via the femoral or iliac artery and tracked through the patient's vasculature to deliver the stent graft to the target site.
Device: Talent Thoracic Stent Graft System
endovascular repair of descending thoracic aneurysms using the Talent Thoracic Stent Graft System.
Other Name: Talent Thoracic Stent Graft System

Detailed Description:

A descending thoracic aneurysm is a bulge in the aorta. The aorta is a large blood vessel that carries blood away from your heart to organs in the rest of your body. Your aneurysm is caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow larger and may ultimately rupture (break open) or extend in size to seriously affect other major arteries in the area. In this clinical study the Talent Thoracic Stent Graft will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system.

Medtronic Vascular submitted a Pre-Market Application (PMA P070007) to the FDA on February 28, 2007, and received market approval for the Talent Stent Graft System on June 5, 2008. As a condition of approval, the FDA has requested a post-market trial. In collaboration with the FDA, Medtronic has designed a post-approval study to document the long-term performance of the Talent Stent Graft System under post market conditions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805948

Contacts
Contact: P J Belmont 707-591-2520 pj.belmont@medtronic.com

  Hide Study Locations
Locations
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Ali Khoynezhad, MD    310-423-3851    khoynezhada@cshs.org   
Contact: Kristin Martiniz    310-423-8762    kristin.martinez@cshs.org   
Principal Investigator: Ali Khoynezhad, MD         
Harbor-UCLA Recruiting
Torrance, California, United States, 90502
Contact: Rodney A White, MD    310-222-2704    rawhite@ucla.edu   
Contact: Abeline Lobue    310-222-2704    alobue@dhs.lacounty.gov   
Principal Investigator: Rodney A. White, MD         
United States, District of Columbia
Washington Hospital D.C. Recruiting
Washington, DC, District of Columbia, United States, 20010
Contact: Frederick P. Beavers, MD    202-877-8050    frederick.p.beavers@medstar.net   
Contact: Darshan Mahida    202-877-6152    darshansinh.mahida@medstar.net   
Principal Investigator: Fred Beavers, MD         
United States, Florida
U Florida at Shands Hospital Recruiting
Gainesville, Florida, United States, 32610
Contact: Robert Feezor, MD    352-273-7020    feezor@surgery.ufl.edu   
Contact: Nancy Hanson    352-273-5479    nancy.hanson@surgery.ufl.edu   
Principal Investigator: Robert Feezor, MD         
Osceola Regional Med Ctr Recruiting
Kissimmee, Florida, United States, 34741
Contact: Matthew Campbell, MD    407-846-0090    mcampbell@heartsurgery-csa.com   
Contact: Debbie Figg    615-604-8707    debbie.figg@scresearch.net   
Principal Investigator: Matthew Campbell, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Joseph Ricotta, MD    404-778-5451    joseph.ricotta@emoryhealthcare.org   
Contact: Sandra Greenwood, RN    404.727.8340    sgreen8@emory.edu   
Principal Investigator: Karthikeshwar Kasirajan, MD         
United States, Illinois
Northwestern MH Recruiting
Chicago, Illinois, United States, 60611
Contact: Heron Rodriguez, MD    312-695-4740    meskanda@nmh.org   
Contact: Rosemary Marcotte    312-695-3410    rmarcotte@nmh.org   
Principal Investigator: Heron Rodriguez, MD         
Southern Illinois University Recruiting
Springfield, Illinois, United States, 62702
Contact: Kim Hodgson, MD    217-545-8856    khodgson@siumed.edu   
Contact: Carol Buettner    217.545.2320    cbuettner@siumed.edu   
Principal Investigator: Kim Hodgson, MD         
United States, Indiana
St. Vincent Heart Center Not yet recruiting
Indianapolis, Indiana, United States, 46290
Contact: Sina Moainie, MD    317-583-7800    smoainie@corvascmds.com   
Contact: Lisa Barnett    317-583-7804    lbarnett@corvascmds.com   
Principal Investigator: Sina Moainie, MD         
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Edwin C. Gravereaux, MD    857-307-1920    egravereaux@partners.org   
Contact: Grace Durrani    617-732-4778    gdurrani@partners.org   
Principal Investigator: Edwin C. Gravereaux, MD         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Manish Mehta, MD    518-218-0148    mehtam@albanyvascular.com   
Contact: Debbie Hill    518-452-2198    hilld@albanyvascular.com   
Principal Investigator: Manish Mehta, MD         
Northshore University Hospital Recruiting
Lake Success, New York, United States, 11042
Contact: Kambhampaty Krishnasastry, MD    516-562-4821    kkrishna@nshs.edu   
Contact: Karen Fehn    516-562-2933    kfehn@nshs.edu   
Principal Investigator: Kambhampaty Krishnasastry, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Charles Hughes, MD    919-668-0903    hughe007@mc.duke.edu   
Contact: Dana Giangiacomo    919-681-1092    Dana.giangiacomo@duke.edu   
Principal Investigator: Charles Hughes, MD         
United States, Ohio
Riverside Methodist Hospital Not yet recruiting
Columbus, Ohio, United States, 43214
Contact: Mitchell Silver, MD    614-262-6772    msilver@mocvc.com   
Contact: Nancy Sample    614-566-1267    n.sample@ohiohealth.com   
Principal Investigator: Mitchell Silver, MD         
University of Toledo Med Ctr Recruiting
Toledo, Ohio, United States, 43615
Contact: Munier Nazzal, MD    419-383-3576    munier.nazzal@utoledo.edu   
Contact: Fran Miller    419-383-6841    francis.miller@utoledo.edu   
Principal Investigator: Munier Nazzal, MD         
United States, Pennsylvania
UPMC Presbyterian Hospital Not yet recruiting
Pittsburg, Pennsylvania, United States, 15213
Contact: Tom Gleason, MD    412-801-8529    gleasontq@upmc.edu   
Contact: Michelle Shirey    412-246-5997    swaneym@upmc.edu   
Principal Investigator: Tom Gleason, MD         
Pinnacle Health Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Brijeshwar Maini, MD    717-731-0101    brij.maini@moffittheart.com   
Contact: Chris Nanna    717.731.0101 ext 3152    chris.nanna@moffittheart.com   
Principal Investigator: Brijeshwar Maini, MD         
United States, Tennessee
Memorial Hospital Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Clifton Reade, MD    423-624-5200    creade@actsurgeons.com   
Contact: Kim Norwood    423-495-2833    kim.norwood@memorial.org   
Principal Investigator: Clifton Reade, MD         
Principal Investigator: Mark Fugate, MD         
Baptist Memorial Hospital Recruiting
Memphis, Tennessee, United States, 38120
Contact: Edward Garrett, MD    901-747-3066    egarrettmd@cvsclinic.com   
Contact: Suzanne Burgar    901-747-1247    suzanne@cvsclinic.com   
Principal Investigator: Edward Garrett, MD         
Tennova Physicians Regional Medical Center Recruiting
Powell, Tennessee, United States, 37849
Contact: George Pliagas, Md    865-938-8121    gpliagas@premiersurgical.com   
Contact: Brenda Wear    865-924-2891    bwear@premiersurgical.com   
Principal Investigator: George Pliagas, MD         
United States, Texas
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Jean Bismuth, MD    713-441-5200    jbismuth@tmhs.org   
Contact: Sharon Reeves    713-441-6536    sdreeves@tmhs.org   
Principal Investigator: Jean Bismuth, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Joseph S. Coselli, MD    832-355-9910    jcoselli@bcm.edu   
Contact: Marisa Martinovich    832.355.9927    martinov@bcm.edu   
Principal Investigator: Joseph S. Coselli, MD         
The Heart Hospital/Baylor Plano Recruiting
Plano, Texas, United States, 38120
Contact: Dennis Gable, MD    972-665-9100    DennisG@baylorhealth.edu   
Contact: Amy Barnette    469.814.5693    Amy.Barnette@baylorhealth.edu   
Principal Investigator: Dennis Gable, MD         
United States, Virginia
Sentara Norfolk General Vascular & Transplant Specialists Recruiting
Norfolk, Virginia, United States, 23507
Contact: Jean Panneton, MD    757-622-2649    jmpanneb@sentara.com   
Contact: Jan Devlin    757-622-2649    jldevlin@sentara.com   
Principal Investigator: Jean Panneton, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Mark H. Meissner, MD    206-221-7047    meissner@u.washington.edu   
Contact: Linda Harrison    206-221-3341    lsh3@u.washington.edu   
Principal Investigator: Mark H. Meissner, MD         
Providence Sacred Heart Recruiting
Spokane, Washington, United States, 99204
Contact: Braden Batkoff, MD    509-455-8820    bbatkoff@spokanecardiology.com   
Contact: Jason Krauss    509-455-8820    jkrauss@spokanecardiology.com   
Principal Investigator: Braden Batkoff, MD         
Sponsors and Collaborators
Medtronic Endovascular
Medtronic
Investigators
Principal Investigator: Adam W Beck, MD University of Florida
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00805948     History of Changes
Other Study ID Numbers: Investigational Plan #109
Study First Received: December 8, 2008
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Endovascular:
thoracic aneurysm
thoracic aortic aneurysms
Thoracic Endovascular Aneurysm Repair (TEVAR)
Talent Thoracic Stent Graft

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on April 17, 2014