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NOT YET RECRUITING
NCT06502938
NA

A Clinical Trial Evaluating the Pan-vascular Interventional Robotic System for Panvascularization Interventional Surgery

Sponsor: Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

PROCEDURE

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