Direct Stent Implantation Using the EXPRESS™ Coronary Stent System: Results of a Multi-Center Feasibility Study

The aim of this prospective, multicenter, single arm study was to assess the safety and feasibility of EXPRESS™ Coronary Stent implantation in native coronary arteries without balloon predilatation. Forty-two patients with de novo or restenotic lesions were enrolled, of which 38 were eligible for analysis. The coronary lesions were predominantly complex, occurring in arteries with a mean reference diameter of 2.80 ± 0.49 mm. Technical and procedural success were achieved in 89.5% and 84% of the cases respectively. The mean minimal lumen diameter increased from 1.08 ± 0.26 mm to 2.55 ± 0.44 mm and diameter stenosis decreased from 61 ± 7% to 13 ± 8%. The primary endpoint of major adverse cardiac events at 30 days was 2.6% and was limited to only one event (target vessel revascularization, nontarget lesion). No other MACE were observed during the three-month follow-up period. Based on the findings of this study, direct stenting with the EXPRESS™ Stent appears feasible and is well tolerated.