NCT06926400

The Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter in the Pre-dilation of Coronary Artery Stenosis Lesions

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter for the Predilation of Coronary Artery Stenosis Lesions

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: JW Medical Systems Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effectiveness and safety of the coronary serrated cutting balloon dilation catheter for the pre-dilation of coronary artery stenosis lesions.

Detailed description

This study is a prospective, multicenter, randomized controlled, non-inferiority designed clinical trial. It is planned to enroll a total of 182 eligible subjects from multiple research centers. The subjects will be randomly assigned to the experimental group (n = 91) and the control group (n = 91) in a 1:1 ratio. All subjects will undergo immediate coronary angiography after percutaneous transluminal coronary angioplasty (PTCA) to evaluate the success rate of the device.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Coronary artery sawtooth cutting balloon dilation catheter	Ninety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a coronary artery sawtooth cutting balloon dilation catheter.
DEVICE	Cutting balloon catheter	Ninety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a cutting balloon catheter.

Timeline

• Start date: 2025-04-10
• Primary completion: 2025-12-30
• Completion: 2026-03-30
• First posted: 2025-04-13
• Last updated: 2025-04-13