DCB vs. DES in Bifurcation Coronary Lesions
NCT Number: NCT06551662
Acronym: PICCOLETO V
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Artery Disease|DCB
Interventions: DEVICE: Paclitaxel drug-coated balloons|DEVICE: Sirolimus drug-coated balloons|DEVICE: New generation drug-eluting stent
Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 321
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-02-01
Locations: Fondazione Ricerca e Innovazione Cardiovascolare, Milano, Italy|First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland, Gdańsk, Poland|Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland, Katowice, 40-635, Poland|Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland, Kraków, Poland|Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland, Kraków, 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, Poznań, 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, Warszawa, Poland|Department of Cardiology, Wałbrzych, Poland|Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University, Wrocław, Poland|Third Department of Cardiology, Medical University of Katowice, Zabrze, Poland|Tan Tock Seng Hospital, Singapore, Singapore

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.

Primary Outcome Measures: CT-scan FFR (Core lab) • Main vessel CT-FFR • Side branch CT-FFR, 9-month Main vessel CT-FFR, 9-month|CT-scan FFR (Core lab) • Main vessel % maximum stenosis • Side branch % maximum stenosis, 9-month Side branch CT-FFR, 9-month
Secondary Outcome Measures: MACE, The MACE was defined as a composite of total mortality, TVR, and spontaneous TV-MI., 24 +/- 1 months|Cardiac death, Cardiac death rates at 24+/- 1 months follow-up, 24+/- 1 months|All-cause death, All-cause death rates at 24+/- 1 months follow-up, 24+/- 1 months|Q-wave MI, Q-wave MI rates at 24+/- 1 months follow-up, 24+/- 1 months|Any MI, Any MI rates at 24+/- 1 months follow-up, 24+/- 1 months|TLR, TLR rates at 24+/- 1 months follow-up, 24+/- 1 months|TVR, TVR rates at 24+/- 1 months follow-up, 24+/- 1 months|Vessel thrombosis, Vessel thrombosis rates at 24+/- 1 months follow-up, 24+/- 1 months|Bleedings following BARC classification, Bleedings following BARC classification at 24+/- 1 months follow-up, 24+/- 1 months