Clinical Report of Drug-Coated Coronary Balloon Dilation Catheter
Interim Clinical Trial Report: Drug-Coated Coronary Balloon Dilation Catheter（Sirolimus）
Identification Code: SM-DCB-202201 | Report Date: 17 March 2025
Study Overview
Design
Multicenter RCT
Prospective, Non-inferiority
Subjects Enrolled (Total)
250
Completed Month 9 Primary Endpoint: 215
Test:108 | Control:107
Primary Endpoint
Diameter Stenosis %
At 9-month post-treatment
Key Inclusion Criteria
- Age ≥18 years with stable/unstable angina or myocardial infarction (≤7 days)
- Reference vessel diameter 2.00–3.00 mm
- Lesion length ≤26 mm
- Stenosis ≥70% (or ≥50% with ischemia)
- TIMI flow grade 3
Key Exclusion Criteria
- Myocardial infarction within 1 week
- NYHA Class IV heart failure
- Severe valvular disease
- Stroke within 6 months
- Contraindications to antiplatelet therapy
Primary Efficacy Endpoint
Target Lesion Segment Diameter Stenosis at 9 Months
14.65 ± 7.18% (FAS)
Defined as: (1 - MLD / RVD) × 100% | Assessed by independent core lab
Procedural Success (FAS)
97.48%
95% CI [92.81%, 99.48%]
Procedural Success (PPS)
99.14%
95% CI [95.29%, 99.98%]
Secondary Efficacy Endpoints (FAS)
Safety Outcomes
30-day MACE Rate
0.85%
(1/118)
Device Thrombosis
0%
(0/215)
SAEs Related to Device
0%
(0/215)
Adverse Events Overview
- Device defects: 0 reported incidents
- Most common AE: Access site hematoma (3.7%)
- All AEs resolved without sequelae
Interim Conclusions
The Drug-Coated Coronary Balloon demonstrated excellent efficacy with a procedural success rate of 97.48% (FAS) and 99.14% (PPS), significantly exceeding the pre-specified OPC of 80%.
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 preliminarily meets clinical requirements for treating de novo coronary small vessel lesions (RVD 2.00-3.00 mm) based on interim analysis.
