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试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Robocath
- 入组人数
- 500
- 试验地点
- 16
- 主要终点
- Technical success
研究概览
简要总结
The main objective of the CHANGE registry is the evaluation of the real-world performance and safety profile of the R-One System in PCI.
详细描述
The R-One system is a class "IIb" CE marked medical device designed to remote deliver and manipulate coronary guidewires and stent/balloon devices during Percutaneous Coronary Intervention (PCI). The system comprises the R-One Robotic Platform used in combination with two accessories, the Mobile Radioprotection Screen and a sterile and single-use R-One Consumable Kit. The R-One is not autonomous and operates only under the operator's commands.
This study is a single-arm, open-label, multi-center registry.
The CHANGE registry, part of the ROBOCATH's post-market clinical follow-up activities, is a real world study aiming to confirm the safety and performance, including the clinical benefit, of the R-One robotic systems medical device.
500 patients with coronary artery disease and with clinical indication for PCI will be recruited in up to Up to 15 centers distributed in Europe and South Africa.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •2.Subjects with coronary artery disease with clinical indication for PCI;
- •3.Subject deemed appropriate for robotic-assisted PCI; and
- •4.The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
排除标准
- •1.Failure/inability/unwillingness to provide informed consent, unless the ethic committee has waived informed consent; or
- •2.The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted PCI.
- •4.Cardiogenic shock
- •5.Subjects will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
结局指标
主要结局
Technical success
时间窗: During procedure
Absence of any unplanned manual assistance or conversion to manual PCI for procedural completion
Clinical success
时间窗: From Day 0 to Day 3
Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the R-One System, without in-hospital major adverse cardiac events (MACE).
次要结局
- Fluoroscopy Time(During procedure)
- Overall Procedure Time(During procedure)
- Radiation exposure for the patient(During procedure)
- Radiation exposure for the operator(During procedure)
- Overall contrast volume(During procedure)
- Safety event occurrence(From Day 0 to Day 3)