A Multicenter Post-Market Study for the Evaluation of the CorPath® GRX technIQ Automated Movements in Percutaneous Coronary Interventions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Major Clinical and Angiographic Complications (MCAC)
研究概览
简要总结
The objective of the present study is to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice.
详细描述
This multi-center, international, randomized, open-label, post-market study will enroll subjects to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice by randomized comparison with a cohort of subjects undergoing robotic-assisted PCI with technIQ automated movements disabled. A secondary objective is to describe the learning curve associated with using technIQ.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or nonpregnant female aged ≥ 20 years.
- •Patients with coronary artery disease with clinical indication for 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.
排除标准
- •Failure/inability/unwillingness to provide informed consent.
- •In the opinion of the investigator, the subject is deemed unsuitable for robotic PCI due to clinical status or anatomic characteristics.
- •Acute STEMI within 72 hours pre-procedure.
结局指标
主要结局
Major Clinical and Angiographic Complications (MCAC)
时间窗: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
The rate of the combined MCAC endpoint (a composite of MACE and Major Clinical and Angiographic Complications) in the technIQ ON group is not significantly higher than in the technIQ OFF group.
Technical Success
时间窗: During the Procedure
Residual stenosis of \<30% in all target lesions with final TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 by angiographic core lab analysis, AND absence of unplanned manual conversion.
次要结局
- PCI procedure time(During the Procedure)
- Major angiographic complications(During the Procedure)
- Serious Adverse Events (SAE)(Procedure through 72 hours postprocedure or hospital discharge (whichever occurs))
- Guidewire Wiring Time(During the Procedure)
- Procedure success(72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.)
- Major adverse cardiovascular events (MACE),(72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.)
- Total Procedural Time(During the Procedure)
- Total Fluoroscopy Time(During the Procedure)
- Subject Radiation Exposure(During the Procedure)
- Planned Manual Conversion (PMC)(During the Procedure)
- Partial Manual Assistance (PMA)(During the Procedure)
- Fluoroscopy Time to Cross Lesion(During the Procedure)
- Contrast Used to Cross Lesion(During the Procedure)
- Subject Radiation Dose(During the Procedure)
- Contrast Fluid Volume(During the Procedure)
- Unplanned Manual Conversion (UMC)(During the Procedure)
- Device Malfunction(During the Procedure)