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Clinical trialNCT06551662RecruitingInterventional

DCB vs. DES in Bifurcation Coronary Lesions

SponsorFondazione Ricerca e Innovazione Cardiovascolare ETSEnrollment321Coronary Artery DiseaseDCB
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

17 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Italy
  • Fondazione Ricerca E Innovazione Cardiovascolare

    Milan, Italy

    Not, yet, recruiting
Poland
  • First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland

    Gdansk, Poland

    Dariusz Cieświerz, MD, PhDMaksymilian Mielczarek, MD, PhDMiłosz Jaguszewski, Prof.
    Not, yet, recruiting
  • Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland

    Katowice, Poland

    Grzegorz Smolka, Prof.Wojciech Wańha, PhDWojciech Wojakowski, Prof.
    Not, yet, recruiting
  • Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland

    Krakow, Poland

    Jacek Legutko, Prof.Paweł Kleczyński, Prof.
    Not, yet, recruiting
  • Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland

    Krakow, Poland

    Stanisław Bartuś, Prof.
    Not, yet, recruiting
  • Department of Cardiology, Copper Health Centre (mcz)

    Lubin, Poland

    Adrian Włodarczak, MD, PhD
    Not, yet, recruiting
  • Clinical Department of Interventional Cardiology, Medical University of Lublin

    Lublin, Poland

    Not, yet, recruiting
  • Department of Cardiology, Poznan University of Medical Sciences

    Poznan, Poland

    Maciej Lesiak, Prof.Miłosz Dziarmaga, MD, PhDSylwia Iwańczyk, MD, PhD
    Not, yet, recruiting
  • Department of Cardiology, the Ministry of Internal Affairs and Administration Hospital, Rzeszow

    Rzeszów, Poland

    Not, yet, recruiting
  • Department of Cardiology and Internal Diseases, Military Institute of Medicine

    Warsaw, Poland

    Not, yet, recruiting
  • Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration

    Warsaw, Poland

    Robert Gil, Prof.Tomasz Pawłowski, Prof.
    Not, yet, recruiting
  • Department of Cardiology

    Wałbrzych, Poland

    Not, yet, recruiting
  • Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University

    Wroclaw, Poland

    Wiktor Kuliczkowski, Prof.
    Not, yet, recruiting
  • Third Department of Cardiology, Medical University of Katowice

    Zabrze, Poland

    Mariusz Gąsior, Prof.
    Not, yet, recruiting
Romania
  • Heart Institute, Cluj-Napoca

    Cluj-Napoca, Romania

    Recruiting
  • Sibiu County Emergency Clinical Hospital

    Sibiu, Romania

    Recruiting
Singapore
  • Tan Tock Seng Hospital

    Singapore, Singapore

    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Aug 2025
Primary completion
1 Feb 2026
Completion
1 Feb 2028
Last update posted
4 Dec 2025
Registered enrollment
321
Registry id
NCT06551662

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.