VALOR: The Talent Thoracic Stent Graft System Clinical Study

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.

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Key information

Conditions

Thoracic Aortic Aneurysms Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Talent Captivia Inclusion Criteria

Patient is at least 18 years of age.
Patient is a surgical or non-surgical candidate
Patient has a:

Fusiform focal TAA AND / OR
Focal saccular TAA or penetrating atherosclerotic ulcer.
Subject's anatomy must meet all of the following anatomical criteria:

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 =/>20mm
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.
Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
Patient must be able and willing to undergo follow-up imaging and examinations postoperatively up to 6 months.

Talent Captivia Exclusion Criteria

Planned placement of the COVERED (top edge of fabric) portion of the stent graft requires implant to occur in zones 0 or 1
Pregnant female
Patient has a connective tissue disease (e.g Marfan's syndrome, medial degeneration).
Patient has a mycotic aneurysm or is suspected of having systemic infection.
Patient has a history of bleeding diathesis, coagulopathy, or refuses blood transfusions.
Patient is currently participating in an investigational drug or device clinical trial that would interfere with the Talent Captivia protocol endpoints or follow-up.
The patient has known allergy or intolerance to the device components.
The patient has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
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.

Treatment and study plan

Talent Thoracic Stent Graft

Device

TEVAR

Primary outcomes

Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit.

Time frame: 12 months
Primary Safety Endpoint: rate of "all cause" mortality of TAA repair with the Talent Thoracic Stent Graft against the literature control for open surgical repair within 1 year of follow-up.

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Official study title

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

Acronym: VALOR

Important dates

Study start: 2003
Primary completion: 2006
Study completion: 2011
First posted: Jan 30, 2008
Registry last updated: Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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