Safety and Efficacy of Valiant Mona LSA Stent Graft System

Not Applicable

Completed

• Conditions: Thoracic Aortic Aneurysms
• Interventions: Device: Valiant Mona LSA Stent Graft System

• Registration Number: NCT01839695
• Lead Sponsor: Medtronic Cardiovascular

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-11
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-25
• Primary Completion: 2014-02
• Results First Submitted: 2014-10-24
• Results First Submitted QC: 2014-10-24
• Results First Posted: 2014-10-29
• Study Completion: 2018-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valiant Mona LSA Stent Graft System	Valiant Mona LSA Stent Graft System	TEVAR procedure using Medtronic Stent Graft

Primary Outcome Measures

Name	Time	Method
Primary Safety Observation - Rate of Major Adverse Events (MAEs)	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	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.

Trial Locations

Locations (3)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Sanger Heart and Vascular Institute; 🇺🇸 Charlotte, North Carolina, United States

St George's Vascular Institute, St. George's Hospital; 🇬🇧 London, United Kingdom