NCT06213714尚未招募不适用
The 5th Generation Tele-Robotic-Assisted Percutaneous Coronary Intervention: A First-in-Human Trial
Yan'an Affiliated Hospital of Kunming Medical University0 个研究点目标入组 12 人开始时间: 2024年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 主要终点
- Clinical Success
研究概览
简要总结
The objective of this study is to examine the safety and effectiveness, from both clinical and technical perspectives, of utilizing the 5G-Robotic VRS100 system in percutaneous coronary intervention (PCI).
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
- 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:
- •De-novo coronary artery 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.
- •Target lesion angiography meets the calculation criteria of Rui-Xin AngioQFA, and AngioQFA is ≤0.8.
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 & LVEF≤35%).
- •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.
- •Target 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).
- •Target lesion/vessel has evidence of intraluminal thrombus.
- •Chronic total occlusion (CTO).
- •Target 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.
- •Target 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
Clinical Success
时间窗: 48 hours 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).
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.
次要结局
- Contrast Fluid Volume(During procedure)
- PCI Procedure Time(During procedure)
- Fluoroscopy and/or X-Ray Time(During procedure)
- Overall Procedure Time(During procedure)
- Patient Radiation Exposure - Cumulative Dose(During procedure)
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