NCT07140822

A Randomized Study of Cutting Balloon Catheter for CAD

A Prospective, Multi-center, Non-inferiority and Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of the Coronary Cutting Balloon Catheter in the Treatment of Coronary Artery Disease (CAD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Shanghai Shenqi Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as a prospective, multi-center, non-inferiority and randomized controlled clinical trial. A total of 158 eligible subjects from 18 sites across the country is planned to be enrolled, and they will be randomly assigned to the test group and the control group according to a ratio of 1:1 for balloon dilatation for the treatment of coronary artery disease.

Conditions

• Coronary Artery Disease
• Percutaneous Coronary Intervention (PCI)
• Calcified Coronary Lesions

Interventions

Type	Name	Description
DEVICE	Coronary Cutting Balloon Catheter	This product uses a pressure device to pressurize the balloon to expand it. The blades designed on the surface of the balloon produce a cutting effect on the vascular lesions, allowing it to better embed into the plaque.
DEVICE	VesscideTM Cutting Balloon System	This product utilizes a pressure mechanism to inflate the balloon, causing it to expand. The blades on the balloon's surface create a cutting action on the vascular lesions, enabling the device to penetrate the plaque more effectively.

Timeline

• Start date: 2023-04-26
• Primary completion: 2023-07-24
• Completion: 2023-10-10
• First posted: 2025-08-26
• Last updated: 2025-08-26

Locations

1 site across 1 country: China