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DCB vs. DES in Bifurcation Coronary Lesions

RecruitingNAAges 18 Years - anyAllFondazione Ricerca e Innovazione Cardiovascolare …
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Subject must be age ≥18 years. * Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission. * Subject understands the trial design and treatment procedures and provides written informal consent before entering the trial * Subject is willing to comply with all protocol-required follow-up evaluations. * Target lesion must be native non-LM bifurcation lesion * Target lesion must be a bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, Medina 1,1,1 or Medina 0,0,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI). * Target lesion reference vessel diameter (both main vessel and side branch) * 2.0 mm by visual estimation. * Target lesion must have visually estimated stenosis ≥50%. * Target lesion length of side branch must be \<25 mm by visual estimation. Exclusion Criteria: * Patient with STEMI (within 3 days from the onset of chest pain to coronarography). * Patient has known allergy to the study balloon/stent system. * Patient has any other serious medical illness that may reduce life expectancy to less than 12 months. * Patient is pregnant or nursing. * Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure. * Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. * In-stent restenosis lesion. * Chronic total occlusion (CTO) lesion in either main vessel or side branch. * Left ventricular ejection fraction \<30%; * Visible and untreatable thrombus at lesion site; * Target lesion/vessel with any of the following characteristics: * Severe and/or \>270° calcification of the target vessel, also proximal to the lesion (intravascular imaging); * Bifurcation lesion where stent strategy is anticipated; * Left main stem stenosis \>50%; * Target lesion is in the left main stem; * Lesions length \>50 mm (main vessel) * Lesions length \>25 mm (side branch)
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What it tests

  • Paclitaxel drug-coated balloons
  • Sirolimus drug-coated balloons
  • New generation drug-eluting stent
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Where

17 sites
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

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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