Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections

Completed

• Conditions: Aortic Aneurysm, Thoracic, Chronic Type B Dissection
• Interventions: Device: Valiant Mona LSA Thoracic Stent Graft System

• Registration Number: NCT02365467
• Lead Sponsor: Medtronic Cardiovascular

Brief Summary

The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the identified subject population. This study will also evaluate the current instructions for use and may direct changes to the delivery and deployment steps.

The purpose of the expansion to the Feasibility Study is to characterize the Valiant Mona LSA Thoracic Stent Graft System, in particular to assess the safety and effectiveness of the device acutely and at the 30 day visit, in subjects enrolled with chronic, Type B dissections.

Detailed Description

The purpose of the clinical investigation is to assess the feasibility of the Valiant Mona LSA Thoracic Stent Graft System to repair fusiform/saccular aneurysms, penetrating ulcers and chronic type B dissections of the DTA in patients who require coverage of the LSA, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the identified subject population. Procedural information will be collected in order to enhance the current instructions for use and delivery and deployment steps.

The chronic Type B Dissection expansion subjects will be prospectively enrolled in support of a future premarket approval analysis for the Valiant Mona LSA device.

Study Timeline

• Study First Submitted: 2015-02-11
• Study First Submitted QC: 2015-02-18
• Study First Posted: 2015-02-19
• Study Start: 2015-04-16
• Primary Completion: 2019-09-20
• Disposition First Submitted: 2020-08-25
• Disposition First Submitted QC: 2020-08-25
• Disposition First Posted: 2021-08-27
• Results First Submitted: 2022-08-16
• Results First Submitted QC: 2022-09-27
• Results First Posted: 2022-10-21
• Status Verified: 2024-12
• Study Completion: 2024-12-05
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Valiant Mona LSA device	Valiant Mona LSA Thoracic Stent Graft System	Treatment with Valiant Mona LSA device

Primary Outcome Measures

Name	Time	Method
30 Day Composite Safety Endpoint	1 month	Within 1 month (Day 0 - Day 30) from the index procedure, composite endpoint consisting of: * Aorta Related Mortality; * Stroke; * Paraplegia; * Left Arm/Hand Ischemia
30 Day Treatment Success	1 month	Treatment success which is defined as technical success (the successful delivery and deployment of the Valiant Mona LSA Thoracic Stent Graft System in the planned location with no unintentional coverage of other vessels, assessed intra-operatively, and the removal of the delivery system) and successful exclusion of the aneurysm or false lumen while maintaining patency of the Main Stent Graft and Branch Stent Graft at 30 day visit. This endpoint is site reported.

Trial Locations

Locations (1)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States