Clinical Report of ShockFast Coronary IVL
ShockFast Intravascular Lithotripsy System
Clinical Trial Summary Report
Study Overview
Study Design
Single-Arm
Multicenter, Prospective
Subjects Enrolled
120
Study Duration
1 Months
Key Inclusion Criteria
- Age 18-80 years with moderate to severe coronary artery calcification
- Reference vessel diameter 2.5-4.0 mm
- Target lesion length 5-40 mm
- Lesion stenosis ≥70% or ≥50% with clinical ischemia
- TIMI flow grade 3 before device use
Primary Efficacy Endpoint
Procedural Success Rate (FAS)
97.48%
95% CI [92.81%, 99.48%]
Procedural Success Rate (PPS)
99.14%
95% CI [95.29%, 99.98%]
Procedural success is defined as successful device delivery and stent implantation with ≤30% residual stenosis and no in-hospital MACE within 7 days.
Secondary Efficacy Endpoints
| Endpoint | FAS Result | PPS Result |
|---|---|---|
| Device Success Rate | 99.16% (118/119) | 100% (116/116) |
| Angiographic Success Rate | 100% (117/117) | 100% (116/116) |
| Secondary Procedural Success Rate | 99.15% (116/117) | 99.14% (115/116) |
| Residual Stenosis (Post-treatment) | 26.50±10.62% | 26.50±10.62% |
| Residual Stenosis (Post-procedure) | 14.65±7.18% | 14.60±7.19% |
| Target Vessel Revascularization | 0.00% | 0.00% |
| In-Stent Thrombosis | 0.00% | 0.00% |
Safety Evaluation
30-day MACE Rate
0.85%
Key Safety Findings
- No device defects reported
- No SAEs related to the investigational device
- No SAEs resulting in death
- Severe angiographic complication rate: 0.00%
- Intraoperative complication rate: 0.00%
- 30-day all-cause mortality rate: 0.00%
Subject Demographics
| Characteristic | Value |
|---|---|
| Mean Age | 65.43 ± 8.65 years |
| Gender (Male/Female) | 63.87% / 36.13% |
| Mean Height | 164.38 ± 7.87 cm |
| Mean Weight | 66.36 ± 11.22 kg |
| Angina History | 94.96% (113/119) |
| Previous PCI | 41.18% (49/119) |
| Previous DES Implantation | 31.93% (38/119) |
Conclusion
The ShockFast Intravascular Lithotripsy System demonstrated excellent efficacy with a procedural success rate of 97.48% (FAS) and 99.14% (PPS), significantly exceeding the protocol-specified OPC of 80%.
The safety profile was favorable with a 30-day MACE rate of 0.85%, no device defects, and no SAEs related to the investigational device.
The device is preliminarily determined to meet clinical application requirements for lumen preparation in patients with moderate to severe calcified coronary artery stenosis.
