Evaluation of the Safety and Effectiveness of the R-One System in Percutaneous Coronary Interventions (PCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 8
- 主要终点
- Clinical success rate of the surgery
研究概览
简要总结
The aim of this study was to evaluate the safety as well as the clinical and technical effectiveness of robotic assisted percutaneous coronary intervention. This was a prospective, single-arm, multicenter, open-label, nonrandomized study. The study protocol was approved by the institutional review boards or local ethics committees of the participating facilities, and all patients provided written informed consent.
Patients with angiographic documentation of obstructive coronary artery disease and evidence of myocardial ischemia were enrolled in the study. Major inclusion criteria were stenosis of target vessel at least 50% by visual estimate, with maximal length of 34 mm and maximal diameter of 4.0 mm, that could be completely covered by a single stent. Major exclusion criteria included planned PCI or coronary artery bypass graft surgery, required treatment of more than 2 coronary artery or more than 1 lesion in each target artery, previous stent implantation within 5.0 mm of the target lesion, target lesion within 5 mm of the artery opening, planned treatment with directional or rotational atherectomy, intraluminal thrombus, severe tortuosity or calcification of the lesion or proximal to it, involvement of a bifurcation, or unprotected left main coronary artery.
All patients underwent PCI with the robotic R-OneTM System (R-One Vascular Robotics, Cathbot). The system was designed for coronary PCI and consists of 2 major components: the command unit and a bedside robot. The command unit is a radiation-shielded, mobile workstation that was positioned in the corner of the catheterization laboratory. The interventional cardiologist sits at the command unit and remotely performs the PCI using the console joysticks. Commands from the control console are delivered as electrical signals along a communication cable that runs from the control console to the robotic drive, on which a sterile cassette is placed. The cassette, which is loaded with the robot and connected to the guiding catheters, imposes axial and rotational forces on the intracoronary devices. The robotic-assisted system is compatible with all commercially available 0.014-inch guidewires, rapid-exchange coronary angioplasty balloons, and stent delivery systems. Fluoro-scopic, electrocardiographic, and hemodynamic images are "slaved" to the duplicate monitors inside the cockpit, enabling visualization from a closer distance. All operators had training on the system that included either animal laboratory experience or using the device to simulate operation before enrolling patients in the study.
After completion of diagnostic angiography, the guiding catheter was positioned at the ostium of the coronary artery and connected to the disposable cassette on the robotic drive. The guidewire was loaded into the cassette before starting the robotic-enhanced PCI. The treatment plan is decided by the doctor according to the patients' situation to perform pre-dilation, stent implantation, post-dilation, or drug balloon. All intracoronary devices were to be manipulated exclusively by the robotic system, with bailout to manual conversion when needed.
The primary endpoints were clinical procedural success and device technical success. Clinical procedural success was defined as <30% residual stenosis and Thrombolysis In Myocardial Infarction (TIMI) grade 3 at the completion of the procedure of robotically-treated lesions as determined by a quantitative coronary angiographic core laboratory, in the absence of major adverse cardiovascular events (MACE), either before hospital discharge or within 30 days of the procedure, whichever occurred first. Major adverse cardiovascular events were defined as cardiac death, Q-wave or non-Q-wave myocardial infarction, or clinically driven target vessel revascularization. All events were adjudicated by an independent clinical events committee. Device technical success was defined as the successful intracoronary advancement and retraction of the PCI devices (guidewire, balloon and stent) by the robotic system, without conversion to manual operation.
The necessary sample size for testing the endpoint of clinical and technical procedural success was calculated on the basis of the target value. The statistical analysis results show that the lower limit of the 95% confidence interval of the clinical success rate and the technical success rate of the operation is greater than 90% of the target value, and the invalid hypothesis is rejected. Both primary endpoints had to be met for the study to be declared successful. Data were analyzed on an intention-to-treat basis. Standard summary statistics were calculated for all patient and study outcome variables. Continuous variables were summarized using estimated means, standard deviations, minimums, maximums, medians, and interquartile ranges. Categorical data were summarized using frequencies, percentages, and 95% confidence interval.
详细描述
Purpose To evaluate the effectiveness of the R-OneTM vascular interventional navigation control system for percutaneous coronary interventions.
To evaluate the safety of the R-OneTM vascular interventional navigation control system for percutaneous coronary interventions.
Research design A prospective, multicenter, single-arm clinical trial. Subjects who met the inclusion criteria and did not meet the exclusion criteria were enrolled into the clinical study. The interventional cardiologists completed the robotic-assisted surgical operation using the investigational device during cardiovascular PCI treatment. The investigator is also required to evaluate the performance of the investigational device during the procedure and ultimately determine the safety and efficacy of its clinical application.
Device The investigational device was R-One Vascular Interventional Navigation Control System developed and produced by Robocath, and was composed of a platform (instruction unit, robot, support joint arm), a mobile radiation-proof screen, and a consumable set (cartridge, instruction unit protective sleeve).
Scope of Trial The subjects scope of the clinical trial: Patients requiring cardiovascular 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria
- •Subjects must meet all of the following inclusion criteria:
- •18 years of age ≤ age ≤ 80 years of age.
- •Have clinical indication(s) for PCI and need to be treated with a PCI procedure.
- •Subjects voluntarily signed an informed consent form and were willing to complete follow-up visits.
- •Angiography Inclusion Criteria
- •Visual description of target lesion diameter stenosis ≥70% (or ≥50% accompanied with clinical evidence of myocardial ischemia within that range;
- •2.5 mm ≤reference vessel diameter by visual description ≤ 4.0 mm.
- •Target lesion length ≤34.0 mm by visual description (If it is made up of multiple small lesions, the distance of which should not exceed 10 mm) and can be fully covered by a single stent. There are no less than 2.0 mm normal segmental vessels at the proximal and distal margins of the diseased region.
- •≤2 target vessels to be treated, one single stent for each target lesion per target vessel, and target lesions can not be treated through stages.
排除标准
- •General Exclusion Criteria
- •Subjects cannot meet any of the following exclusion criteria:
- •Subjects have undergone other PCI within 72 hours prior to the R-One PCI procedure;
- •Subjects have undergone PCI within 30 days prior to the R-One PCI procedure and have experienced a MACE or other serious adverse event;
- •Acute myocardial infarction (MI) within one week prior to scheduled R-One PCI procedure;
- •Severe heart failure (NYHA ≥ Class III);
- •Cardiogenic shock within 48 hours prior to the PCI procedure;
- •Pregnant and lactating women, or women with plans to become pregnant during the clinical trial;
- •Subjects with allergies to aspirin, heparin, clopidogrel, contrast media, metallic materials and rapamycin;
- •Subjects with a platelet count <100 x 109/L or >700 x 109/L and a white blood cell (WBC) count <3 x 109/L (e.g., thrombocytopenia, thrombocytosis, neutropenia or leukopenia);
- •Subjects with creatinine levels ≥ 177 umol/L;
- •Subjects had a stroke within 30 days prior to the planned R-One PCI procedure.
- •Subjects with an active peptic ulcer or upper gastrointestinal hemorrhage within 6 months prior to the PCI procedure.
- •Subjects with a history of massive haemorrhage or coagulation disorder, or refusal of blood transfusion within the previous 6 months.
- •Subjects are currently enrolled in another clinical study that has not yet completed the entire follow-up period.
- •The investigators determined that the patient was not applicable for robot-assisted PCI.
- •Angiography Exclusion Criteria
- •TIMI blood flow grade of <3 for the target lesion.
- •In-stent restenosis, or the target vessel has implanted a stent previous which in close proximity to the target lesion.
- •Need other treatments (e.g., atherectomy or laser treatment) in addition to balloon angioplasty and stentoplasty.
- •2 or more lesions in a single vessel that need treatment concurrently;
- •Bifurcation lesions requiring protection;
- •Visible thrombosis;
- •Target lesion located in the left coronary artery trunk;
- •Target lesion within 5 mm of left anterior descending (LAD), left circumflex (LCX) or right coronary artery (RCA) opening;
- •Severe distorted and/or calcified lesions, and its coronary anatomy is not applicable for robot-assisted PCI according to the the investigator.
研究组 & 干预措施
Evaluate safety and efficacy of the R-One vascular interventional navigation control system for PCI
干预措施: R-One vascular interventional navigation control system (Device)
结局指标
主要结局
Clinical success rate of the surgery
时间窗: Day of surgery
Clinical success rate = number of subjects that were clinical successes ÷ number of subjects that received surgical treatment × 100%. Evaluation Method: 1. The target lesion was treated with test device, and the residual stenosis in the target vessel (visual description by angiography) reduced to less than 30% after PCI and a TIMI grade of 3. 2. No major adverse cardiovascular events (MACE) occurred in the hospital.
Success rate of surgical techniques
时间窗: Day of surgery
Technical success rate = number of subjects that were technical successes ÷ number of subjects received surgical treatment × 100% Evaluation Method: The Robot-assisted PCI procedure was successfully completed without any unplanned manual assistance or shift to manual operation. 1. Definition of planned manual assistance: During robotic surgery: Reposition of guidewires or stents/balloons, manual translation/rotation of guidewires or stents/balloons to guiding catheters, reposition of guiding catheters and usage of any device that is not compatible with the robotic platform 2. Definition of unplanned manual assistance: Manual translation/rotation of the guidewire and/or manual translation of the stent/balloon once the guidewire has left the guiding catheter 3. Definition of the shift to manual operation: Any situation during the PCI procedure that results in the shift to manual operation. System restart failure during robotic surgery
次要结局
- Radiation exposure to interventional cardiologists(Day of surgery)
- Procedure duration(Day of surgery)
- Duration of robot-assisted treatment(Day of surgery)
- Radiation exposure to the patient(Day of surgery)
- Radiation exposure to interventional cardiologists(Day of surgery)
- Contrast dose(Day of surgery)
- MACE(Day of surgery and 1 month post-operative)