NCT06032572尚未招募不适用
Evaluation of the Safety and Effectiveness of the VRS100 Robotic Console System in Percutaneous Coronary Interventions: A Multicenter, Randomised, Non-inferiority Trial (ESSENCE)
Shenzhen Raysight Intelligent Medical Technology Co., Ltd.3 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2023年9月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 204
- 试验地点
- 3
- 主要终点
- Technical Success
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of the clinical and technical performance of the VRS100 system with disposable surgical kit in the delivery and manipulation of coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria:
- •Age ≥18 years.
- •Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI).
- •The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- •Angiographic Inclusion Criteria:
- •In situ primary coronary vascular disease.
- •Reference vessel diameter is 2.5-4.0mm by visual estimate.
- •Target lesion length is ≤30.0mm.
- •Target lesion is a single de novo native coronary artery lesion. This lesion may consist of multiple lesions (with ≤10mm between diseased segments) and must be completely covered by a single stent with ≥5.0mm of normal segments on proximal and distal edges of the lesion.
- •Target lesion diameter showing stenosis ≥70% by visual estimate, or ≥50% with myocardial ischemia.
排除标准
- •Patients meeting any of the following criteria will be excluded:
- •General Exclusion Criteria:
- •Subjects with indications for urgent PCI surgery.
- •Evidence of an acute myocardial infarction within one week prior to the intended VRS100 procedure.
- •Subject has undergone PCI within 72 hours prior to the VRS100 procedure.
- •Subject has undergone PCI within 30 days prior to the VRS100 procedure and experienced a MACE or a serious adverse event (SAE).
- •Severe heart failure (NYHA IV).
- •Subject has suffered a stroke, or has an active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to planned VRS100 procedure.
- •Subject has known hypersensitivity or contraindication to aspirin, heparin, ticagrelor, clopidogrel, bivalirudin, PTX(paclitaxel), stainless steel, etc.
- •Subject has acute or chronic kidney disease (serum creatinine level of >2.5 mg/dL or >221 umol/L) or need dialysis.
- •Pregnant or breastfeeding, or planning to be pregnant.
- •Repeated enrollment.
- •Any other factors that the researchers consider not suitable for inclusion or completion of this study.
- •Angiographic Exclusion Criteria:
- •Any previous stent placement within 5.0 mm (proximal or distal) of the target lesion.
- •The study lesion requires planned treatment with directional coronary atherectomy (DCA), laser, rotational atherectomy or any device except for balloon dilatation prior to stent placement.
- •Cardiac allograft vasculopathy (CAV).
- •The study vessel has evidence of intraluminal thrombus.
- •Chronic total occlusion (CTO).
- •The study lesion located in a native vessel distal to an ostial, bifurcation or anastomosis.
- •Unprotected left main coronary artery disease defined as an obstruction greater than 50% diameter stenosis in the left main coronary artery.
- •The study lesion or vessel proximal to the target lesion has severe tortuosity or calcification.
- •Target lesion that cannot be fully covered by a single stent.
- •more than 2 lesions requires treatment in one vessel.
- •Subject requires treatment of more than one vessel.
结局指标
主要结局
Technical Success
时间窗: 1 day
Defined as the successful advancement and retraction of PCI devices using the VRS100 System and without conversion to manual operation.
Clinical Success
时间窗: 48-hrs or hospital discharge, whichever occurs first
Defined as angiographic success (residual stenosis after stenting of \<30% with final TIMI \[Thrombolysis In Myocardial Infarction\] flow grade 3) without an in-hospital major adverse cardiovascular event (MACE) (cardiovascular death, MI, clinically driven target vessel revascularization).
次要结局
- PCI Procedure Time(During procedure)
- Overall Procedure Time(During procedure)
- Fluoroscopy and/or X-Ray Time(During procedure)
- Patient Radiation Exposure - Cumulative Dose(During procedure)
- Contrast Fluid Volume(During procedure)
- Performance of the Experimental Device(During procedure)
研究者
研究点 (3)
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