NCT06551662

DCB vs. DES in Bifurcation Coronary Lesions

Drug-coated Balloons vs. Drug Eluting Stents in Bifurcation Coronary Lesions: PICCOLETO V Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 321 (estimated)
• Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator-driven prospective, multicentric, international, randomized clinical study, in an open-label randomized fashion, where patients with bifurcation coronary artery disease (Medina: 111,101,011,001) in vessels with diameter \>2.0 (visual estimation) and with a clinical indication to PCI, will be enrolled. After successful predilatation (with any tool deemed useful), patients will be randomized 1:1:1 to SCB, PCB or standard treatment with DES for bifurcation native vessel disease. All patients with a clinical indication for PCI, both stable coronary artery disease and acute coronary syndrome, will be enrolled. Before participating all the candidates will be clearly informed about the study, including the possible risks and benefits, and will be asked to provide a written informed consent. Subjects will be instructed that may not meet the general criteria for inclusion or the angiographic criteria, or that may have at least one exclusion criteria, and then be excluded from the study (screening failure), even after informed consent is obtained. Consecutive patients who meet at least one of the inclusion criteria and none of the exclusion criteria, will participate to the study. After randomization, the procedure will consist in standard coronary angioplasty following international guidelines/consensus documents and as per local practice. If the patient has been randomized to SCB or PCB, it is mandatory to adequately prepare the lesion.

Conditions

• Coronary Artery Disease
• DCB

Interventions

Type	Name	Description
DEVICE	Paclitaxel drug-coated balloons	Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent
DEVICE	Sirolimus drug-coated balloons	Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent
DEVICE	New generation drug-eluting stent	Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-02-01
• Completion: 2028-02-01
• First posted: 2024-08-13
• Last updated: 2025-12-04

Locations

17 sites across 4 countries: Italy, Poland, Romania, Singapore