PICCOLETO V

Study Chairman: Prof. Bernardo Cortese
Study P.I. Wojciech Wanha
Steering committee: Wojciech Wanha, Sylwia Iwankzic, Leontin Lazar, Bharat Kialani, Sara Malakouti, Bernardo Cortese

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) and drug-eluting stents (DES) in coronary artery disease patients with de novo bifurcation lesions. The trial will test the noninferiority of each DCB arm in terms of fractional flow reserve (FFR) score by CT scan or coronary angiography after 9 months vs DES (provisional stenting), and clinical outcomes of major adverse cardiac events (MACE) after 12 months. The results of this trial will provide important insights into the most effective treatments options for patient with de novo bifurcation lesions, and will also test the safety, feasibility and efficacy of a full-DCB solution for true bifurcation lesions.

First patient in Poland enrolled on Oct 5, 2026

Are you interested in participating in the study?

Update: PICCOLETO V enrolled the first patient on July 17th , 2025.

THE STUDY SITES AND CENTERS