Piccoleto V

The PICCOLETO V trial is an international, multicenter, investigator-driven, open-label, randomized clinical trial that aims to compare the short- and long-term performance of both paclitaxel and sirolimus drug-coated balloons (DCB) with drug-eluting stents (DES) in coronary artery disease patients with de novo bifurcation lesions. The trial will measure the noninferiority of the DCB arm in terms of fractional flow reserve (FFR) score by CT scan after 9 months and clinical outcomes of major adverse cardiac events (MACE) after 12 months, compared to the DES arm. The results of this trial will provide important insights into the most effective treatments options for patient with de novo bifurcation lesions.