Clinical Report of Drug-Coated Coronary Balloon Dilation Catheter
Clinical Trial Summary Report
Drug-Coated Coronary Balloon Dilation Catheter for Coronary Small Vessel Lesions
Summary
This was a multicenter, randomized, controlled, non-inferiority study to evaluate the safety and efficacy of the investigational Drug-Coated Coronary Balloon Dilation Catheter (rapamycin-coated) compared to a control Paclitaxel-Releasing Coronary Balloon Dilation Catheter for the treatment of primary coronary small vessel lesions (2.00 mm ≤ RVD ≤ 3.00 mm, length ≤ 26 mm).
Primary Endpoint: Percentage diameter stenosis within the target lesion segment at 9 months post-procedure.
Conclusion: The investigational device was non-inferior to the control device regarding the primary efficacy endpoint and demonstrated a comparable safety profile, with a significantly lower rate of target lesion restenosis.
📊 Trial Design
- Sponsor: Shunmei Medical Co., Ltd.
- Design: Multicenter, Randomized (1:1), Controlled, Non-inferiority
- Sample Size: 250 subjects (125 per group)
- Control Device: Paclitaxel-Releasing Balloon (Zhuhai Cardionovum)
- Follow-up: 1, 6, 9 (angiography), 12 months
📈 Key Results
- Primary Endpoint (FAS): LSMean difference: -5.50% (95% CI: -12.31 to 1.30). Upper CI limit < 8% → Non-inferiority met.
- Target Lesion Restenosis (≥50%): 12.4% (Trial) vs 24.0% (Control), P=0.0332.
- MACE Rate: 16.1% (Trial) vs 26.6% (Control), P=0.0432.
- Device Success Rate: ~97% in both groups.
Detailed Efficacy & Safety Outcomes
✅ Primary Efficacy Endpoint (9-Month % Diameter Stenosis)
Full Analysis Set (FAS):
Trial Group LSMean: 48.67% (95% CI: 43.03–54.32)
Control Group LSMean: 54.18% (48.63–59.72)
Difference (Trial – Control): -5.50% (-12.31 to 1.30)
→ Upper confidence limit (1.30%) < non-inferiority margin (8%) → Non-inferiority achieved.
📉 Secondary Efficacy Endpoints
Interventional Success
~97% in both groups (P > 0.9999)
Late Lumen Loss (LLL)
0.21±0.46 mm (Trial) vs 0.27±0.48 mm (Control), P=0.5979
Restenosis (≥50%)
12.4% (Trial) vs 24.0% (Control)
P=0.0332
🛡️ Safety Endpoints
- Major Adverse Cardiovascular Events (MACE): 16.1% vs 26.6% (P=0.0432) – significantly lower in Trial group.
- Target Lesion Revascularization (TLR): 9.3% vs 13.9% (P=0.3124).
- Device-Related Thrombosis: None in either group.
- Device Defects: None reported.
- Serious Adverse Events (SAEs): 20.8% vs 33.6% (P=0.0326).
🎯 Conclusion
The Drug-Coated Coronary Balloon Dilation Catheter (Shunmei Medical) is non-inferior to the marketed Paclitaxel-Releasing Balloon (A domestic brand) in treating coronary small vessel lesions regarding 9-month percentage diameter stenosis.
It showed a significantly lower target lesion restenosis rate (12.4% vs 24.0%) and a lower overall MACE rate, with a comparable safety profile and no device-related thrombosis or defects.
The trial supports the safety and efficacy of the rapamycin-coated balloon in Chinese patients with small coronary artery disease.
Report No.: SM-DCB-CSR20250922 | Version: V1.0 / September 28, 2025
Statistical Analysis: Shanghai Renzhi Data Technology Co., Ltd.
