Thoracic Aortic Aneurysms Clinical Trial
Official title:
Valiant Mona LSA Stent Graft System Early Feasibility Study
Verified date | June 2023 |
Source | Medtronic Cardiovascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | December 2018 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St George's Vascular Institute, St. George's Hospital | London | |
United States | Sanger Heart and Vascular Institute | Charlotte | North Carolina |
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Medtronic Cardiovascular |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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