Background : Carvedilol is a direct inhibitor of smooth muscle cell proliferation and migration, and produces a significant suppression of neointimal hyperplasia in our previous animal experiment. The purpose of the study was to examine the safety and efficacy of carvedilol-eluting BiodVysio (Biocompatibles Ltd., London, United Kingdom) stent implantation on coronary de novo lesions. Methods : We performed a prospective randomized trial to compare two types of stents for the revascularization in 39 patients [Group I (carvedilol-eluting stent): n=20, 58.3짹11.1 years, 16 male, and Group II (control stent): n=19, 59.9짹8.5 years, 15 male]. Clinical, angiographic, and intravascular ultrasound analysis was performed at six-month follow-up. Results : All stents were successfully deployed and patients were discharged home without clinical events. Baseline clinical characteristics, baseline diameter stenosis and minimal luminal diameter (MLD) were not different between the two groups. Stent size and length were not different between the two groups (3.30짹0.25mm, 16.8짹1.5mm in group I vs 3.34짹0.23mm, 16.7짹1.5mm in group II). Follow-up MLD and late loss were significantly lower in the group I compared with group II (2.30짹0.48mm vs. 1.60짹0.72mm, p=0.037; and 0.53짹0.36 mm vs. 1.23짹0.75 mm; p=0.033, respectively). And, the restenosis rates were significantly lower in the group I (0% vs. 27.3%, p=0.202). During clinical follow-up at 100% patients, there were no myocardial infarction, any death, bypass surgery. The TLR rates and total MACE of control stent group were relatively higher compared with carvedilol-eluting stent group [0%(0/20) vs. 10.5%(2/19); p=0.231 and 0%(0/20) vs. 15.8%(3/19), p=0.106, respectively]. Conclusion : Implantation of carvedilol-eluted BiodVysio stents appears feasible and safe, showing low rates of binary restenosis and revascularization. These results warrant further confirmation with a large, randomized multicenter trial.