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VALOR: The Talent Thoracic Stent Graft System Clinical Study | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

VALOR: The Talent Thoracic Stent Graft System Clinical Study

Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms

NCT00604799•Medtronic Cardiovascular

Summary

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 Research Study a device will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system. Information will be collected on the performance for the device for 5 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Patient is at least 18 years of age.
•2. Patient is a surgical or non-surgical candidate
•3. Patient has a:
•1. Fusiform focal TAA AND / OR
•2. Focal saccular TAA or penetrating atherosclerotic ulcer.
•4. Subject's anatomy must meet all of the following anatomical criteria:
•1. iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories
•2. non-aneurysmal aortic diameter in the range of 18-42mm; and
•3. non-aneurysmal aortic proximal and distal neck lengths =/\>20mm
•5. Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CTA) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram (MRA) obtained within the previous three (3) months prior to the implant procedure.
+2 more criteria

Exclusion Criteria

•1. Planned placement of the COVERED (top edge of fabric) portion of the stent graft requires implant to occur in zones 0 or 1
•2. Pregnant female
•3. Patient has a connective tissue disease (e.g Marfan's syndrome, medial degeneration).
•4. Patient has a mycotic aneurysm or is suspected of having systemic infection.
•5. Patient has a history of bleeding diathesis, coagulopathy, or refuses blood transfusions.
•6. Patient is currently participating in an investigational drug or device clinical trial that would interfere with the Talent Captivia protocol endpoints or follow-up.
•7. The patient has known allergy or intolerance to the device components.
•8. The patient has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
•9. The patient has another medical condition, which may cause them to be non-compliant with the protocol, confound the data interpretation, or limited life expectancy of less than 6 months.

Locations (1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

July 1, 2003

Primary Completion Date

June 1, 2006

Completion Date

June 1, 2011

Last Updated

November 2, 2021

Enrollment

379

ACTUAL participants

Conditions

Thoracic Aortic Aneurysms

Interventions

Talent Thoracic Stent Graft

DEVICE

Endovascular Treatment of Thoracic Aortic Disease

NCT00583817

Thoracic Aortic AneurysmsDissecting, Aneurysm+7 more

View study

COMPLETEDNA

Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

NCT00435942

Thoracic Aortic Aneurysmsand Penetrating Atherosclerotic Ulcers

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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