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

NCT00805948 | Terminated Results

• 1 other identifier: Investigational Plan #109
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 26

Brief Summary

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.

Conditions

Thoracic Aortic Aneurysms

Keywords

thoracic aneurysm; thoracic aortic aneurysms; Thoracic Endovascular Aneurysm Repair (TEVAR); Talent Thoracic Stent Graft

Outcome Measures

Primary Outcomes (1)

• Freedom From Aneurysm-related Mortality at 5 Years

  For all THRIVE subjects, Aneurysm-Related Mortality (ARM) is defined as: Death from rupture of the thoracic aortic aneurysm or from any procedure intended to treat the Descending Thoracic Aneurysm (DTA - fusiform aneurysms and saccular aneurysms/penetrating ulcers) as determined by an independent Clinical Events Committee (CEC). If a death occurred within 30 days of any procedure intended to treat the DTA, then it is presumed to be aneurysm related, unless there is evidence to the contrary.

  5 years

Other Outcomes (3)

• All-Cause Mortality

  1, 12, 24, 36, 48 and 60 months

• Number of Participants With Conversion to Surgery

  1, 12, 24, 36, 48 and 60 months

• Number of Participants With Aneurysm Rupture

  1, 12, 24, 36, 48 and 60 months

Study Arms (2)

DeNovo

EXPERIMENTAL

Prospectively enrolled subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.

Device: Talent Thoracic Stent Graft System

Valor

NO INTERVENTION

Historical control arm, consisting of 195 subjects from the VALOR Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol. The data from these subjects will be combined with the data from the subjects implanted after commercial release (DeNovo) to comprise the final analysis cohort for the THRIVE Study

Interventions

Talent Thoracic Stent Graft System DEVICE

endovascular repair of descending thoracic aortic aneurysms using the Talent Thoracic Stent Graft System.

DeNovo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiovascular: lead
• Medtronic: collaborator

Study Sites (26)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Harbor-UCLA

Torrance, California, 90502, United States

Location

Washington Hospital D.C.

Washington D.C., District of Columbia, 20010, United States

Location

U Florida at Shands Hospital

Gainesville, Florida, 32610, United States

Location

Osceola Regional Med Ctr

Kissimmee, Florida, 34741, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern MH

Chicago, Illinois, 60611, United States

Location

Southern Illinois University

Springfield, Illinois, 62702, United States

Location

St. Vincent Heart Center

Indianapolis, Indiana, 46290, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Northwell Health Inc

Great Neck, New York, 11021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

University of Toledo Med Ctr

Toledo, Ohio, 43615, United States

Location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Pinnacle Health

Wormleysburg, Pennsylvania, 17043, United States

Location

Memorial Hospital

Chattanooga, Tennessee, 37404, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Tennova Physicians Regional Medical Center

Powell, Tennessee, 37849, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

The Heart Hospital/Baylor Plano

Plano, Texas, 38120, United States

Location

Sentara Norfolk General Vascular & Transplant Specialists

Norfolk, Virginia, 23507, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Providence Sacred Heart

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Michael McGuffey, Clinical Research Director
• Organization: Medtronic, Inc

michael.mcguffey@medtronic.com

707-591-7126

Study Officials

• Adam W Beck, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 10, 2008
• Study Start: April 1, 2009
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: September 27, 2021
• Results First Posted: August 14, 2019

Record last verified: 2021-09

Locations

US (26)