Valiant Mona LSA Stent Graft System Early Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 5
- Primary Endpoint
- Primary Safety Observation - Rate of Major Adverse Events (MAEs)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Primary Safety Observation - Rate of Major Adverse Events (MAEs)
Time Frame: 1 month
Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia.
Primary Effectiveness Observation
Time Frame: 1 month
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.
Secondary Outcomes
No secondary outcomes reported