NCT06110988Unknown不适用
A Clinical Study for Pan-vascular Interventional Control System in Percutaneous Coronary Intervention
Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年4月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Technical Success
研究概览
简要总结
The goal of this prospective, single-center, single-arm study is to explore the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI), researchers will assess the clinical success, technical success, and record the intraoperative data (PCI time, guidewire operation time, dose of contrast medium, radiation exposure doses, etc). All subjects will be followed up on the day of surgery, before discharge (or 48 hours after surgery) and 1 month after surgery to observe the safety indicators.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. General Inclusion criteria:
- •18 years old ≤ age ≤80 years old;
- •have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study);
- •Subjects or their legal representative has been informed of the nature of the study, signed informed consent and were willing to cooperate in the follow-up.
- •2. Angiographic inclusion criteria:
- •study lesion is a single de novo native coronary artery lesion (previously untreated coronary artery disease);
- •target vessel diameter between 2.5 mm and 4.0 mm;
- •single lesion length ≤38 mm, with at least 2.0 mm normal segments on the proximal and distal edges of the lesion;
- •stenosis ≥50% and < 100%.
排除标准
- •1. General exclusion criteria:
- •hemodynamic instability (including hypotension or use of vasopressors to maintain blood pressure);
- •STEMI, cardiopulmonary resuscitation, or cardiogenic shock within 7 days before surgery;
- •subjects were required to undergo planned PCI or CABG within 30 days after surgery, or had undergone PCI within 72 hours before surgery, or had undergone PCI within 30 days before surgery with a protocol-defined major adverse coronary event (MACE) or serious adverse event (SAE);
- •subjects had a stroke or transient ischemic attack (TIA) within 30 days before surgery;
- •subjects with active peptic ulcer or upper GI bleeding within 6 months before surgery;
- •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
- •left ventricular ejection fraction (LVEF) < 35%;
- •subjects with known allergies to or contraindications to antiplatelet drugs, anticoagulants, stent materials and their coatings, or allergies to contrast agents, unable to receive adequate preoperative medication or manage with clinically appropriate alternatives;
- •subjects had a history of bleeding tendency or coagulopathy or refused blood transfusion;
- •severe liver and kidney dysfunction;
- •patients who are scheduled to undergo additional cardiac surgery (e.g., valve replacement or cardiac ablation) within 30 days after surgery;
- •inaccessible vascular access (radial artery/femoral artery) or severe vascular stenosis, occlusion or skin infection at the puncture site;
- •uncontrolled severe infection;
- •subjects participating in clinical studies of other devices or drugs during the same period;
- •pregnant and lactating women of childbearing age;
- •subjects judged by the investigator to be ineligible for the study.
- •2. Exclusion criteria for angiography:
- •in-stent restenosis or any previous stent placement within 5.0 mm (proximal or distal) of the target lesion；
- •bifurcation lesions, in which the target vessel branch needs to be protected but cannot be protected;
- •the target lesion is located at the ostium or anastomosis of coronary artery;
- •investigate evidence of intravascular thrombosis;
- •severe tortuosity or calcification of the proximal end of the study vessel or target lesion;
- •study the complete occlusion of the lesion;
- •Target lesion located in left main coronary artery, or unprotected left main coronary artery disease (> 50% stenosis in left main coronary artery).
结局指标
主要结局
Technical Success
时间窗: Procedure
Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.
Clinical Success
时间窗: Discharge or 48 hours post intervention, whichever comes first
Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the Pan-vascular interventional robotic system, without in-hospital major adverse coronary events (MACE).
次要结局
- Procedure Time(Procedure)
- PCI time(Procedure)
- Contrast agent dosage(Procedure)
- Fluoroscopy Time(Procedure)
- Radiation Exposure(Procedure)
研究者
Ge Junbo
Chief of Cardiology
Shanghai Zhongshan Hospital
研究点 (2)
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