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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
321
Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with 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
Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent
Fondazione Ricerca e Innovazione Cardiovascolare
Milan, Italy
NOT_YET_RECRUITINGFirst Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
Gdansk, Poland
NOT_YET_RECRUITINGDepartment of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Katowice, Poland
NOT_YET_RECRUITINGDepartment of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland
Krakow, Poland
NOT_YET_RECRUITINGSecond Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
Krakow, Poland
NOT_YET_RECRUITINGDepartment of Cardiology, Copper Health Centre (MCZ)
Lubin, Poland
NOT_YET_RECRUITINGClinical Department of Interventional Cardiology, Medical University of Lublin
Lublin, Poland
NOT_YET_RECRUITINGDepartment of Cardiology, Poznan University of Medical Sciences
Poznan, Poland
NOT_YET_RECRUITINGDepartment of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow
Rzeszów, Poland
NOT_YET_RECRUITINGDepartment of Cardiology and Internal Diseases, Military Institute of Medicine
Warsaw, Poland
NOT_YET_RECRUITING...and 7 more locations
6-9 Month CT-FFR or Invasive FFR in Bifurcation Lesions
6-9-month CT-scan FFR (core lab) * 6-9-month Main vessel CT-FFR * 6-9-month Side branch CT-FFR or If invasive coronary angiography indicated at 6-9 months: * invasive FFR of Main vessel * invasive FFR of Side branch
Time frame: 6-9-month
6-9-Month CT-FFR or Invasive FFR: % Max Stenosis (Main + Side Branch)
6-9-month CT-scan FFR (core lab): * Main vessel % maximum stenosis * Side branch % maximum stenosis or If invasive coronary angiography indicated at 6-9 months: * Main vessel % maximum stenosis * Side branch % maximum stenosis
Time frame: 6-9-month
MACE
The MACE was defined as a composite of total mortality, TVR, and spontaneous TV-MI.
Time frame: 24 +/- 1 months
Cardiac death
Cardiac death rates at 24+/- 1 months follow-up
Time frame: 24+/- 1 months
All-cause death
All-cause death rates at 24+/- 1 months follow-up
Time frame: 24+/- 1 months
Q-wave MI
Q-wave MI rates at 24+/- 1 months follow-up
Time frame: 24+/- 1 months
Any MI
Any MI rates at 24+/- 1 months follow-up
Time frame: 24+/- 1 months
TLR
TLR rates at 24+/- 1 months follow-up
Time frame: 24+/- 1 months
TVR
TVR rates at 24+/- 1 months follow-up
Time frame: 24+/- 1 months
Vessel thrombosis
Vessel thrombosis rates at 24+/- 1 months follow-up
Time frame: 24+/- 1 months
Bleedings following BARC classification
Bleedings following BARC classification at 24+/- 1 months follow-up
Time frame: 24+/- 1 months
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