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NOT YET RECRUITING
NCT07233317
NA

Evaluating the Safety and Effectiveness of a Vascular Interventional Robotic System in Assisting With Percutaneous Coronary Intervention Procedures: A Prospective, Multicenter, Randomized Controlled Clinical Trial

Sponsor: China National Center for Cardiovascular Diseases

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to verify the safety and effectiveness of the vascular interventional robotic system developed and manufactured by Beijing Zhongke Hongtai Medical Technology Co., Ltd. in assisting percutaneous coronary intervention procedures in patients with coronary artery disease. The main question it aims to answer is: 1. Whether the PCI-assisted procedure was clinically successful and technically successful? 2. Will the PCI-assisted procedure can reduce procedure time, PCI time, and radiation exposure for both operators and patients?? Researchers will compare the vascular interventional robotic system with human operators to see if using the vascular interventional robotic system in PCI procedure is effective and safe. Participants will undergo percutaneous coronary interventions with the vascular interventional robotic system or human operator based on the randomization results. Then all participants will receive a 1-month follow up to evaluate the primary and secondary endpoints.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2025-12-01

Completion Date

2026-06-30

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

DEVICE

vascular interventional robotic system

Patients all undergoing PCI with vascular interventional robotic system

DEVICE

human operator

Patients undergoing PCI by human operators

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Xicheng District, China