NCT06502938

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

To Evaluate Percutaneous Coronary Intervention Assisted by the Control System of Panvascular Interventional Surgery Efficacy and Safety Clinical Trials

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: Shenzhen Institute of Advanced Biomedical Robot Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-07-15
• Completion: 2025-12-15
• First posted: 2024-07-16
• Last updated: 2024-07-16

Locations

5 sites across 1 country: China