A Prospective, Multicenter, Two-cohorts, Single Arm Study Evaluating Safety, Effectiveness and Performance of Angimis Atherectomy System for the Treatment of Non-crossable and/or Non-dilatablE Lesions in CorONary Arteries Disease (NEON Study).

Overview

NEON study is a prospective, multicenter, two-cohorts, single arm study evaluating safety, effectiveness and performance of Angimis Atherectomy System for the treatment of Non-crossable and/or Non-dilatable in Coronary Arteries Disease. The primary endpoint assesses the effectiveness of the Angimis Atherectomy System by evaluating its angiographic success defined as final TIMI flow grade 3 with residual stenosis ≤30% on quantitative coronary angiography after the procedure of balloon and/or stent implementation validated by an independent, centralized core laboratory. The secondary safety endpoint assesses the rate of major complications before discharge, procedural success is defined as angiographic success without severe procedural complications (death, perforation, flow limiting dissection, acute vessel closure, or stent thrombosis) after the procedure, and clinical success defined as procedural success without complications during admission: cardiovascular death, target lesion revascularization, probable or definite stent thrombosis, stroke, and Bleeding Academic Research Consortium grade 3b or higher bleeding at 3, 6 and 12 months after the procedure. The secondary performance endpoint assesses the device technical success defined as successful preparation, delivery and use of the investigational device according to the IFU, including delivery of the laser catheter to the intended treatment location, successful delivery of laser energy, completion of the intended laser treatment without device malfunction, and retrieval of the device without device-related failure. Llaser success defined as successful lesion modification attributable to the investigational device, demonstrated by either a) successful advancement of the laser catheter across the target lesion with effective laser-mediated plaque ablation, or b) effective plaque ablation produced by laser energy delivered proximal to the lesion, enabling subsequent balloon crossing and lesion expansion that would otherwise not have been achievable.

This NEON study is a prospective, multicentre, two cohort, open-label non-comparative study, conducted up to 5 clinical sites in Europe and Asia. The primary objective of the NEON study is to generate clinical evidence demonstrating the safety and clinical performance of the Angimis Atherectomy System in subjects with non-dilatable and non-crossable coronary lesions, in support of the MDR conformity assessment. The primary endpoint will be evaluated against a predefined Performance Goal derived from historical clinical evidence using a non-inferiority statistical framework. In addition, only for the non-dilatable cohort, a pilot phase (6 patients) will be conducted to evaluate the safety of Angimis Atherectomy System by assessing the Rate of major complications before discharge. The pivotal phase will commence after the initial safety profile is confirmed from the pilot phase. For the uncrossable lesion, there is only the pivotal phase as part of this clinical investigation. Primary endpoint: The primary effectiveness endpoint will assess the proportion of treated subjects in whom angiographic success was achieved. Angiographic success is defined as final TIMI flow grade 3 with residual stenosis ≤30% on quantitative coronary angiography after the procedure of balloon or stent implementation validated by an independent, centralized core laboratory. A maximum of two target lesions may be treated with the investigational device during the index procedure. Where two target lesions are treated, one lesion shall be prospectively designated by the investigator, prior to treatment, as the Primary Target Lesion. The primary effectiveness endpoint will be assessed exclusively on the Primary Target Lesion. One additional Target Lesion may be treated during the same procedure when clinically indicated; data related to this lesion will be collected separately and included in secondary performance and safety analyses. Treatment of more than two Angimis-treated target lesions during the same index procedure is not planned in this clinical investigation. Secondary endpoint: 1\. Safety: 1\) Rate of major complications before discharge as predefined previously 2) This endpoint will be assessed immediately after the procedure and will determine the number of patients in whom procedural success was achieved. 3\) This endpoint will be evaluated at 3, 6, and 12 months after the procedure and will measure the proportion of treated subjects in whom clinical success was achieved 2. Performance: 1. Device Technical Success, defined as successful preparation, delivery, and use of the investigational device according to the IFU, including delivery of the laser catheter to the intended treatment location, successful delivery of laser energy, completion of the intended laser treatment without device malfunction, and retrieval of the device without device-related failure. 2. Laser Success, defined as successful lesion modification attributable to the investigational device, demonstrated by either: * successful advancement of the laser catheter across the target lesion with effective laser-mediated plaque ablation; or * effective plaque ablation produced by laser energy delivered proximal to the lesion, enabling subsequent balloon crossing and lesion expansion that would otherwise not have been achievable The secondary performance endpoint will evaluate the laser success rate during the procedure. 3\. User handling: User handling will be assessed during the procedure based on the following points: 1. Pushability of the catheter, 2. Crossability of the catheter, 3. Retrievability of the catheter, 4. readability of the system interface. 5. Operability of the system User handling procedures will ensure standardized and consistent data collection across all participating sites in different countries. Investigators and site users will be trained to record procedural details precisely, including the catheter diameter used, angiographic findings, and post-procedural assessments. Specific instructions will be provided to ensure consistent evaluation and documentation of these performance characteristics across users and regions. Data entry interfaces will be configured to minimize variability between users and centres, with controlled terminology and predefined ranges to ensure homogeneity of reporting.