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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).

Sponsor: Shenzhen Tonglu Technology Co., Ltd

Summary

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.

Official title: A Prospective, Multicentre, Two-cohorts Single-arm Clinical Investigation 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).

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