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).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 123
- 主要终点
- The primary effectiveness endpoint will assess the proportion of treated subjects in whom angiographic success was achieved.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of age > 18 years old.
- •Stenosis lesion ≥ 70% diameter stenosis as assessed by visual estimation.
- •Visionally estimated the reference vessel diameter to be ≥ 2.0 mm to allow the passage of guidewire.
- •Subject has at least one non-crossable and/or non-dilatable stenosis lesion. Target lesion belongs to one of the following conditions:
- •Coronary artery lesions previously treated with Drug-Eluting Stent (DES) or Bare-Metal Stent (BMS), including in-stent restenosis or stent under-expansion; or
- •Chronic Total Occlusion (CTO) with an estimated occlusion time of ≥ 3 months and with TIMI flow 0-1 confirmed by Coronary angiography; or
- •De novo coronary lesions with failed balloon angioplasty, defined as residual diameter stenosis >50% and/or TIMI flow 0-2 after high-pressure balloon inflations, confirmed by coronary angiography.
- •Subject can understand the purpose of the NEON study and has signed voluntarily the informed consent form and is agreeing to the scheduled follow up requirements
排除标准
- •Evidence of acute ischemic events
- •Evidence of severe valvular pathology, based on echocardiogram result according to the investigator's assessment.
- •Evidence of < 30% Left Ventricular Ejection Fraction (LVEF) based on Echocardiogram results
- •Cardiogenic and non-cardiogenic shock within 3 months.
- •Active bleeding or coagulopathy
- •Previous coronary angioplasty within 3 months of the index procedure
- •Patients participating in another trial for which the primary endpoint has not be reached
- •Acute or Chronic renal failure, Impaired renal function (serum creatinine > 2.5 mg/dl or 221 umol/l) determined within 72 hours prior to index procedure.
- •Known allergies to the following: Aspirin, Clopidogrel or Ticlopidine, Heparin, Sirolimus or its derivatives, contrast agent (that cannot be adequately pre-medicated), or any metal
- •Planned surgery within 6 months of enrolment in this study
- •Life expectancy is less than 6 months
- •Patients known to be suffering from substance abuse (alcohol or drug)
- •Patients with any other significant co-morbid illness which, in the opinion of the investigator, are not conducive to inclusion in the study.
- •Known or suspected Pregnancy and breastfeeding population. Childbearing potential and unwilling to use contraception to control.
- •Patients not willing to provide written informed consent
- •In the investigators' opinion, subjects will not be able to comply with the follow-up requirements.
- •Patients with bifurcation and Ostial lesions
结局指标
主要结局
The primary effectiveness endpoint will assess the proportion of treated subjects in whom angiographic success was achieved.
时间窗: Immediate after the procedure
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
次要结局
未报告次要终点