This study evaluates the safety and efficacy of the new CrossFlex stent in the treatment of native coronary artery disease. The CrossFlex stent is a flexible, balloon-expandable new device with an excellent flexibility, radial strength, conformability, and radio-opacity. Little data are available concerning the clinical and angiographic outcomes of this device. The CrossFlex stent was implanted in 209 consecutive patients with 226 lesions. Follow-up angiography was performed at 6 months, and clinical evaluation was undertaken at regular intervals after stent implantation. Procedural success was achieved in all lesions without in-hospital complications. Angiographic follow-up data were available in 153 of the 187 eligible lesions (follow-up rate, 82%), and the overall angiographic restenosis rate was 16.3%. Minimal lumen diameter immediately after stent placement was the only predictor of angiographic restenosis. Clinical follow-up was obtained in all patients at 10.5 +/- 5.2 months. There were 4 deaths (1 cardiac in origin, the others noncardiac in origin), and 1 nonfatal myocardial infarction (nonstented artery) during follow-up. Target lesion revascularization was required in 15 patients (7%), and the overall event-free survival rate (death, myocardial infarction, and repeat revascularization) was 87% at the end of the follow-up period. The CrossFlex stent is a safe and effective device with a high procedural success rate, and a favorable late clinical outcome for treatment of native coronary artery disease. Further randomized trials are needed to compare the CrossFlex stent with standard slotted-tube stents.