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Coated balloons versus drug stents for heart artery branch blockages

Compares drug-coated balloons with drug-releasing stents in adults with coronary artery disease at a split.

Key facts

Who runs it
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Where
Gdansk, Katowice, Krakow, Lubin, Lublin, Poznan, Rzeszów, Wałbrzych, Warsaw, Wroclaw, and Zabrze, PolandSee the 13 sitesAlso in 3 other countries, 4 sites
Trial code
Registry title
DCB vs. DES in Bifurcation Coronary Lesions
Status
Recruiting
People taking part
321 people, planned
Started
1 Aug 2025
Expected to end
1 Feb 2028
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Paclitaxel drug-coated balloons
  • Sirolimus drug-coated balloons
  • New generation drug-eluting stent
Record updated
4 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a narrowing (stenosis) at a fork in a heart artery (a bifurcation lesion) who need a stent or balloon procedure (PCI) to open it.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Native bifurcation lesion, not in the left main artery, with at least 50% narrowing. Silent ischemia, stable or unstable angina, or a heart attack older than 1 week. Side branch lesion shorter than 25 mm.

Main reasons for not taking part

  • Heart attack with ST elevation (STEMI) within 3 days of chest pain
  • Pregnant or nursing
  • Other serious illness that may shorten life to less than 12 months
  • In-stent restenosis or chronic total occlusion
  • Left ventricular ejection fraction below 30%

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Left ventricular ejection fraction <30%
  • 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)

Where in Poland

Also in 3 other countries, 4 sites

  • First Department of Cardiology, Medical University of Gdansk, Gdansk, PolandGdansk, PolandContact: Maksymilian Mielczarek, Prof.Not yet recruiting
  • Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, PolandKatowice, PolandContact: Wojciech Wańha, MD, PhDNot yet recruiting
  • Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, PolandKrakow, PolandContact: Jacek LegutkoNot yet recruiting
  • Second Department of Cardiology, Jagiellonian University Medical College, Krakow, PolandKrakow, PolandContact: Stanisław Bartuś, Prof.Not yet recruiting
  • Department of Cardiology, Copper Health Centre (MCZ)Lubin, PolandContact: Adrian Włodarczak, MD, PhDNot yet recruiting
  • Clinical Department of Interventional Cardiology, Medical University of LublinLublin, PolandContact: Piotr WacińskiNot yet recruiting
  • Department of Cardiology, Poznan University of Medical SciencesPoznan, PolandContact: Sylwia Iwańczyk, MD, PhDNot yet recruiting
  • Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, RzeszowRzeszów, PolandContact: Piotr Wańczura, MD, PhDNot yet recruiting
  • Department of CardiologyWałbrzych, PolandContact: Jacek BezubkaNot yet recruiting
  • Department of Cardiology and Internal Diseases, Military Institute of MedicineWarsaw, PolandContact: Piotr Kwiatkowski, MDNot yet recruiting
  • Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and AdministrationWarsaw, PolandContact: Robert Gil, Prof.Not yet recruiting
  • Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical UniversityWroclaw, PolandContact: Wiktor Kuliczkowski, Prof.Not yet recruiting
  • Third Department of Cardiology, Medical University of KatowiceZabrze, PolandContact: Mariusz Gąsior, Prof.Not yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Device: Paclitaxel drug-coated-balloonsTreatment being tested

    Treatment: Paclitaxel drug-coated balloons

  • Device: Sirolimus drug-coated-balloonsTreatment being tested

    Treatment: Sirolimus drug-coated balloons

  • Device: new generation drug-eluting-stentsExisting treatment, for comparison

    Treatment: New generation drug-eluting stent

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Drug-coated Balloons vs. Drug Eluting Stents in Bifurcation Coronary Lesions: PICCOLETO V Study
Plain-language title
Coated balloons versus drug stents for heart artery branch blockagesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
4 December 2025