Drug Coated Balloon Compared to Bare Metal Stent for de Novo Coronary Artery Lesions

This randomized trial will assess the efficacy of Drug Coated Balloon (DCB) compared to Bare Metal Stent (BMS) using Fractional Flow Reserve (FFR) guidance for de novo coronary artery lesions in patients unable to tolerate dual antiplatelet therapy and at high risk of bleeding. Patients will be randomized after balloon angioplasty to receive either DCB or BMS. Endpoints are late luminal loss at 9 months, and major adverse cardiac events including arterial thrombosis at 1, 9 and 12 months.