Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT02365467
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:
NCT02365467
Study Brief:
Protocol Section:
NCT02365467