Clinical Trial Report for Coronary Cutting Balloon Catheter
SafeCut Coronary Cutting Balloon Dilatation Catheter Clinical Trial Report
Study Overview
NMPA Registration No.: 20203030164
Trial Methodology
After signing the informed consent form and meeting the inclusion/exclusion criteria, subjects were randomized 1:1 to either the test or control group via an electronic randomization system. Upon logging into the system and submitting subject information, the investigator received the randomization result and used the corresponding device (cutting balloon) for treatment. Angiography was performed pre- and post-intervention. Follow-up was conducted pre-discharge and at 30 days post-procedure.
Acute Lumen Gain Results
Device Success Rate Analysis
| Item | Test Group | Control Group | Test Statistic | P-value |
|---|---|---|---|---|
| Device Success Rate | 0.02(CMH Chi-square) | 0.8871 | ||
| Not Successful | 2.35% (2/85) | 2.53% (2/79) | ||
| Successful | 97.65% (83/85) | 97.47% (77/79) | ||
| Missing | 1 | 3 | ||
Note: This study was designed as a non-inferiority trial. If the lower limit of the 95% confidence interval (CI) for the between-group difference is greater than -10%, the test product can be considered to have achieved the expected effectiveness.
Clinical Trial Conclusion
Effectiveness Results
- Regarding acute lumen gain (post-pre), the test group was significantly superior to the control group (P=0.0047).
- The mean lumen gain was 1.49±0.45 mm in the test group and 1.30±0.37 mm in the control group.
- The device success rate was 97.65% in the test group and 97.47% in the control group.
- The 95% confidence interval for the between-group difference was -4.32% to 4.99%, with the lower limit greater than the non-inferiority margin of -10%.
Safety Results
- No significant difference in device success rate was found between the two groups (P=1.0000).
- The incidence of adverse events in the test group was comparable to that in the control group.
- Both groups demonstrated good safety profiles at the 30-day follow-up.
Final Clinical Conclusion
This study confirms that the Coronary Cutting Balloon Dilatation Catheter produced by Shenzhen Shunmei Medical Co., Ltd., in the treatment of coronary artery disease, demonstrates comparable effectiveness and safety to the control device (Boston Scientific Cutting Balloon Catheter), meeting the primary endpoint of the non-inferiority trial. The test group even showed a statistically significant advantage in acute lumen gain. This product can provide a new effective treatment option for clinical practice.
