VALOR: The Talent Thoracic Stent Graft System Clinical Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Thoracic Aortic Aneurysms

Intervention / Treatment
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* Device: Talent Thoracic Stent Graft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test (Enrollment Completed)<br>Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair whom are low to moderate risk (0, 1, & 2) per the modified SVS/AAVS criteria who meet inclusion/exclusion criteria. The aneurysm must be at least 20 mm distal to the left common carotid artery & 20 mm proximal to the origin of the celiac artery. | Device: Talent Thoracic Stent Graft<br>* TEVAR<br>|
| Other: Registry (Enrollment Completed)<br>Surgical candidates of low to moderate risk (SVS 0, 1, 2) that meet the Registry Inclusion/Exclusion criteria. | Device: Talent Thoracic Stent Graft<br>* TEVAR<br>|
| Other: High Risk (Enrollment Completed)<br>Patients that meet one or more of the following: High Risk (SVS 3) Non-surgical candidates not associated with SVS scoring Traumatic thoracic injuries | Device: Talent Thoracic Stent Graft<br>* TEVAR<br>|
| Other: Talent Captivia (Recruiting)<br>Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair who meet inclusion/exclusion criteria. | Device: Talent Thoracic Stent Graft<br>* TEVAR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit. |  | 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. |  | 12 months |