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DCB vs. DES in Bifurcation Coronary Lesions
Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS
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.
Official title: Drug-coated Balloons vs. Drug Eluting Stents in Bifurcation Coronary Lesions: PICCOLETO V Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
321
Start Date
2025-08-01
Completion Date
2028-02-01
Last Updated
2025-12-04
Healthy Volunteers
No
Conditions
Interventions
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
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
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
Locations (17)
Fondazione Ricerca e Innovazione Cardiovascolare
Milan, Italy
First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
Gdansk, Poland
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Katowice, Poland
Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland
Krakow, Poland
Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
Krakow, Poland
Department of Cardiology, Copper Health Centre (MCZ)
Lubin, Poland
Clinical Department of Interventional Cardiology, Medical University of Lublin
Lublin, Poland
Department of Cardiology, Poznan University of Medical Sciences
Poznan, Poland
Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow
Rzeszów, Poland
Department of Cardiology and Internal Diseases, Military Institute of Medicine
Warsaw, Poland
Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration
Warsaw, Poland
Department of Cardiology
Wałbrzych, Poland
Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University
Wroclaw, Poland
Third Department of Cardiology, Medical University of Katowice
Zabrze, Poland
Heart Institute, Cluj-Napoca
Cluj-Napoca, Romania
Sibiu County Emergency Clinical Hospital
Sibiu, Romania
Tan Tock Seng Hospital
Singapore, Singapore