Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
321 participants
INTERVENTIONAL
2025-08-01
2028-02-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Device: Paclitaxel drug-coated-balloons
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
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-stents
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
Interventions
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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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Fondazione Ricerca e Innovazione Cardiovascolare ETS
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Bernardo Cortese
Role: primary
Piotr Kwiatkowski, MD
Role: primary
Jacek Bezubka
Role: primary
Other Identifiers
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PICCOLETO V
Identifier Type: -
Identifier Source: org_study_id
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