NCT07233317

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	vascular interventional robotic system	Patients all undergoing PCI with vascular interventional robotic system
DEVICE	human operator	Patients undergoing PCI by human operators

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: China