📅 Trial Timeline

Started: June 12, 2025 (first subject enrolled)

Ended: August 20, 2025 (last subject completed)

Duration: ~2.5 months

👥 Participants

Screened: 183 subjects

Enrolled (Randomized): 168 subjects

Treatment Group: 84 subjects

Control Group: 84 subjects

🎯 Primary Endpoint: Device Success Rate

Statistical Conclusion (FAS): The 95% CI for the difference in success rates was [-3.94%, 6.41%]. Since the lower limit (-3.94%) > non-inferiority margin (-10%), non-inferiority was achieved.

📈 Secondary Efficacy Endpoints:

• Procedural Success Rate: 100% in both groups
• Target Lesion Failure (TLF): 0% at all time points in both groups
• Patient-Oriented Composite Endpoint (POCE):
  • Immediately post-procedure & before discharge: 0% in both groups
  • At 1-month follow-up: 2.38% (2/84) in treatment group vs. 0% in control group (P>0.05, not statistically significant)

Key Safety Notes: No serious adverse events related to the investigational device (grades 3-5) occurred. No adverse events led to participant withdrawal from the trial.

This prospective, multicenter, randomized controlled clinical trial demonstrated that Shunmei Medical's Coronary Cutting Balloon Dilatation Catheter is non-inferior in efficacy and comparable in safety to a leading U.S. brand of coronary cutting balloon in patients with coronary artery disease.

The trial met its primary endpoint with a device success rate of 97.62% vs. 96.39% (control), satisfying the non-inferiority hypothesis. Both groups showed 100% procedural success, no TLF events, and similar safety profiles with no device-related serious adverse events.

The clinical trial successfully validates the safety and efficacy of Shunmei Medical's Coronary Cutting Balloon Dilatation Catheter for the treatment of coronary artery disease.