Multicenter Registry on Robotically Assisted Percutaneous Coronary Interventions - TESLA Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 6
- 主要终点
- Number of participants with clinically successful PCI
研究概览
简要总结
MulTicenter rEgiStry on RoboticalLy Assisted percutaneous coronary interventions- TESLA registry is a retrospective registry evaluating the safety and efficacy of robotically assisted PCI with the CorPath GRX System (Corindus Vascular, Siemens Healthineers, Germany) in real-world interventional cardiology practice.
详细描述
R-PCI represents a novel approach to performing PCI with several studies showing high technical success and low complication rates. The CorPath GRX System is the second generation of the CorPath platform, dedicated to advancing robotic-assisted vascular procedures to mitigate the orthopaedic and radiation-related occupational hazards associated with the practice of interventional cardiology.
MulTicenter rEgiStry on RoboticalLy Assisted percutaneous coronary interventions- TESLA registry is a retrospective registry evaluating the safety and efficacy of robotically assisted PCI with the CorPath GRX System (Siemens Healthineers, Germany) in real-world interventional cardiology practice in Europe and Asia.
All patients who underwent R-PCI (defined as completion of at least one procedural step robotically) with the CorPath GRX System and completed one-year follow-up are eligible for recruitment in this registry, if older than 18 years. This study includes patients with either stable coronary artery disease, unstable angina, or acute myocardial infarction (MI).
The Study Investigators expect to enroll at least 700 patients (up to 1000). International centers that performed R-PCI with the CorPath GRX System will be invited to participate in this multicenter study.
Baseline, procedural, and follow-up data will be collected for all cases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Older than 18 years,
- •Patients with either stable coronary artery disease, unstable angina, or acute myocardial infarction (MI),
- •Coronary artery lesions considered suitable for R-PCI with CorPath GRX System.
排除标准
- •Unwillingness to provide informed consent (only if applicable).
结局指标
主要结局
Number of participants with clinically successful PCI
时间窗: From time of procedure until date of first event or death from any cause, which came first, assessed up to the time of discharge in the index hospitalization
Clinical success, 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) (death, target vessel MI, or need of repeat target vessel revascularization);
次要结局
- Number of participants with ischemia-driven target lesion revascularization (TLR)(1 year post-procedure)
- Patient radiation exposure(During the procedure)
- Number of participants with target vessel failure (TVF)(1 year post-procedure)
- Procedure time(During the procedure)
- Contrast volume(During the procedure)
- Number of participants with target lesion failure (TLF)(1 year post-procedure)