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RECRUITING
NCT06551662
NA

DCB vs. DES in Bifurcation Coronary Lesions

Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS

View on ClinicalTrials.gov

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

Interventions

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

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