Trials Sponsors Conditions Drugs Pricing

Conditions

Thoracic Aortic Aneurysms

Keywords

thoracic aneurysmthoracic aortic aneurysmsThoracic 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 SystemDevice

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

DeNovo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Medtronic Cardiovascular
Industrylead
Medtronic
Industrycollaborator

Study Sites (26)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Harbor-UCLA

Torrance, California, 90502, United States

Washington Hospital D.C.

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

U Florida at Shands Hospital

Gainesville, Florida, 32610, United States

Osceola Regional Med Ctr

Kissimmee, Florida, 34741, United States

Emory University

Atlanta, Georgia, 30322, United States

Northwestern MH

Chicago, Illinois, 60611, United States

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Results Point of Contact

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

Study Officials

Adam W Beck, MD
University of Florida
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

349 participants (actual enrollment reported by the registry).

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 2009

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Other Outcomes (3)

Study Arms (2)

DeNovo

Valor

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Other Outcomes (3)

Study Arms (2)

DeNovo

Valor

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations