Summary Report of Clinical Trial for Peripheral Intravascular Lithotripsy ShockFast System
Summary Report of Clinical Trial for Peripheral
ShockFast-IVL System
Trial Design
Design Type: Prospective, multi-center, open-label, randomized, parallel-controlled, superiority trial
Primary Endpoint: Technical Success Rate
Follow-up Period: Immediately post-procedure, pre-discharge, 30 days (±7 days) post-procedure
Statistical Unit: Peking University Clinical Research Institute
Definition of Primary Endpoints
Efficacy Results
Primary Endpoint: Technical Success Rate
| Group | Technical Success Rate |
|---|---|
| Test Group (n=62) | 96.77% (60/62) 95% CI [88.83%, 99.61%] |
| Control Group (n=58) | 68.97% (40/58) 95% CI [55.46%, 80.46%] |
The 95% confidence interval for the difference in technical success rates is [13.87%, 41.43%], with the lower limit greater than the superiority margin of 0.
Secondary Endpoints
| Endpoint | Test Group (n=62) | Control Group (n=58) | Intergroup Difference P-value |
|---|---|---|---|
| Primary Patency Rate | 70.18% | 77.36% | P=0.393 |
| ABI Improvement | 0.45 ± 0.38 | 0.43 ± 0.26 | P=0.783 |
| Rutherford Classification Improvement | 73.68% | 79.25% | P=0.734 |
All secondary endpoints showed no statistically significant difference between groups (P>0.05)
Safety Results
| Safety Metric | Test Group (n=62) | Control Group (n=58) |
|---|---|---|
| Intraoperative Complications | 0 cases (0.00%) | 0 cases (0.00%) |
| Serious Adverse Events | 7 events (11.29%) | 6 events (10.34%) |
| Device Deficiencies | 0 cases (0.00%) | 0 cases (0.00%) |
| AE Incidence Rate | 35.48% | 46.55% |
Study Conclusion
The peripheral ShockFast-IVL system demonstrated significant superiority over the control device in the primary endpoint of technical success rate (96.77% vs 68.97%, P<0.05), establishing superiority. Secondary endpoints showed no statistical differences. Safety evaluation indicated no additional risks associated with the test device, with no device deficiencies reported.
The device demonstrated favorable efficacy and safety in treating moderate-to-severe calcified lesions in femoropopliteal arteries.
