NCT06551662Recruiting
DCB vs. DES in Bifurcation Coronary Lesions
Drug-coated Balloons vs. Drug Eluting Stents in Bifurcation Coronary Lesions: PICCOLETO V Study
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 321 (estimated)
- First submitted
- 30 Jul 2024
- Start date
- 1 Aug 2025
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
- Diseases
- Coronary artery disease
- NCT number
- NCT06551662
What you commit to
- Study type: Interventional
- Planned participants: 321
- From 1 Aug 2025 to the primary completion date, 1 Feb 2026
- 17 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Left ventricular ejection fraction \<30%;
Other
- Patient with STEMI (within 3 days from the onset of chest pain to coronarography).
- 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.
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Ricerca e Innovazione Cardiovascolare Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland Coordinator of this site? Confirm its status | Gdansk | Poland | Not yet recruiting |
| Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland Coordinator of this site? Confirm its status | Katowice | Poland | Not yet recruiting |
| Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland Coordinator of this site? Confirm its status | Krakow | Poland | Not yet recruiting |
| Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland Coordinator of this site? Confirm its status | Krakow | Poland | Not yet recruiting |
| Department of Cardiology, Copper Health Centre (MCZ) Coordinator of this site? Confirm its status | Lubin | Poland | Not yet recruiting |
| Clinical Department of Interventional Cardiology, Medical University of Lublin Coordinator of this site? Confirm its status | Lublin | Poland | Not yet recruiting |
| Department of Cardiology, Poznan University of Medical Sciences Coordinator of this site? Confirm its status | Poznan | Poland | Not yet recruiting |
| Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow Coordinator of this site? Confirm its status | Rzeszów | Poland | Not yet recruiting |
| Department of Cardiology Coordinator of this site? Confirm its status | Wałbrzych | Poland | Not yet recruiting |
| Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Department of Cardiology and Internal Diseases, Military Institute of Medicine Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University Coordinator of this site? Confirm its status | Wroclaw | Poland | Not yet recruiting |
| Third Department of Cardiology, Medical University of Katowice Coordinator of this site? Confirm its status | Zabrze | Poland | Not yet recruiting |
| Heart Institute, Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Sibiu County Emergency Clinical Hospital Coordinator of this site? Confirm its status | Sibiu | Romania | Recruiting |
| Tan Tock Seng Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.