Safety and Efficacy of Valiant Mona LSA Stent Graft System

Study Overview
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Brief Summary
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The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms of the descending thoracic aorta (DTA) in patients who require coverage of the left subclavian artery (LSA).The study is intended to assess safety and performance of the device acutely and at 30 days.

Official Title
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Valiant Mona LSA Stent Graft System Early Feasibility Study

Conditions
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Thoracic Aortic Aneurysms

Intervention / Treatment
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* Device: Valiant Mona LSA Stent Graft System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years of age. The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form Subject must be considered a candidate for revascularization of the LSA. Subject has a DTA which will require coverage of the LSA Subject's anatomy must meet the anatomical criteria to receive that implanted device Exclusion Criteria: Subject has had previous endovascular repair of the ascending and/or descending thoracic aorta. Subject is in acute renal failure or has renal insufficiency with a serum creatinine ≥ 2.0 mg/dL Subject is a pregnant female. Enrollment in another clinical study Subject has had a cerebral vascular accident (CVA)or myocardial infarction (MI) within 3 months. Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion. Subject has a known allergy or intolerance to the device components. Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valiant Mona LSA Stent Graft System<br>TEVAR procedure using Medtronic Stent Graft | Device: Valiant Mona LSA Stent Graft System<br>* All subjects will be implanted with this device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Observation - Rate of Major Adverse Events (MAEs) | Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia. | 1 month | 
| Primary Effectiveness Observation | Treatment success which is defined as technical success (successful delivery and deployment of the stent graft in the planned location with no unintentional coverage of other vessels, assessed intraoperatively, and the removal of the delivery system) and successful exclusion of the aneurysm while maintaining patency of the MSG and BSG at the 30 day visit. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TEVAR, Thoracic Aneurysm, Endovascular Aortic Repair