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A Clinical Trial Evaluating the Pan-vascular Interventional Robotic System for Panvascularization Interventional Surgery
Sponsor: Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.
Summary
The purpose of this prospective, randomized, open, parallel controlled, multicenter trial is to investigate the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI). Investigators will evaluate clinical success, technical success, and record intraoperative data (PCI time, total operating time, contrast agent dose, radiation exposure dose, etc.). All subjects were followed up on the day of surgery, before discharge and 1 month after surgery to observe the safety indicators.
Official title: To Evaluate Percutaneous Coronary Intervention Assisted by the Control System of Panvascular Interventional Surgery Efficacy and Safety Clinical Trials
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
159
Start Date
2024-07-15
Completion Date
2025-12-15
Last Updated
2024-07-16
Healthy Volunteers
No
Conditions
Interventions
Pan-vascular interventional robotic system
Pan-vascular interventional robotic system assited PCI for delivery and manipulation of guidewires, catheters, and quick exchange balloon dilatation catheters/stents.
Traditional artificial percutaneous coronary intervention
Doctors perform traditional percutaneous coronary intervention
Locations (5)
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital,Sun Yat-sen University
Guanzhou, Guandong, China
Linfen Central Hospital
Shanxi, Linfen, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China