Study Overview

Study Design

Prospective, multicenter, randomized controlled, non-inferiority trial. The experimental group used the Coronary Rapamycin Targeted Eluting Stent System, while the control group used the Cobalt Chromium Everolimus Eluting Coronary Stent System (Abbott Vascular).

Key Inclusion Criteria

• Age 18-75 years, male or female
• Indicated for PCI
• Target lesion: primary coronary stenosis, single lesion
• Target lesion length ≤48mm, target vessel diameter 2.0-5.0mm
• Target lesion diameter stenosis ≥70% (or ≥50% with myocardial ischemia evidence)
• Left ventricular ejection fraction (LVEF) ≥40%, NYHA functional class ≤III

Primary Efficacy Evaluation

Secondary Efficacy Evaluation

Device Delivery System Performance

All 160 patients (80 in experimental group, 80 in control group) demonstrated excellent delivery system performance in pushability, lesion crossing, lesion coverage, support, deployment and retrieval, and radiopacity, with convenient and reliable operation.

Safety Evaluation

Adverse Events

This interim analysis reported no device-related serious adverse events (SAE) or adverse events leading to study termination. Adverse event rates at 1, 6, 9, and 12 months post-procedure will be analyzed in the final report.

Subject Baseline Characteristics

Interim Conclusions

• The Coronary Rapamycin Targeted Eluting Stent System demonstrates excellent safety profile with zero intraoperative complications and device deficiencies
• Device and procedure success rates achieved 100% in both experimental and control groups
• No target lesion failure, target lesion revascularization, or stent thrombosis events reported at 1-month follow-up
• Delivery system performance meets all clinical requirements with excellent operational characteristics
• Study enrollment completed successfully with 100% retention rate across 11 participating centers
• Primary endpoint evaluation will be conducted upon completion of 9-month follow-up for all patients