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Drug-coated balloons versus drug-eluting stents for coronary bifurcation blockages

Drug-coated Balloons vs. Drug Eluting Stents in Bifurcation Coronary Lesions: PICCOLETO V Study

Not applicable Interventional Fondazione Ricerca e Innovazione Cardiovascolare ETS · NCT06551662

This trial will test whether paclitaxel or sirolimus drug-coated balloons work as well as a new-generation drug-eluting stent for adults undergoing PCI of native bifurcation coronary lesions.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment321 (estimated)
Ages18 Years and up
SexAll
SponsorFondazione Ricerca e Innovazione Cardiovascolare ETS Academic / other
Locations17 sites (Milan and 16 other locations)
Trial IDNCT06551662 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, international, open-label randomized study that enrolls adults with native coronary bifurcation lesions (specified Medina patterns) and a clinical indication for PCI. After successful predilatation, eligible patients are randomized 1:1:1 to a paclitaxel‑coated balloon, a sirolimus‑coated balloon, or a new-generation drug‑eluting stent for treatment of the bifurcation. Key angiographic criteria include vessel diameters >2.0 mm, side-branch length <25 mm, and ≥50% stenosis by visual estimate. Both stable coronary disease and acute coronary syndromes (outside early STEMI) are included and patients will be followed for clinical outcomes after the procedure.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with native non–left-main coronary bifurcation lesions of the specified Medina patterns, vessel diameters >2.0 mm, ≥50% stenosis, side‑branch length <25 mm, and a clinical indication for PCI (stable angina, silent ischemia, or recent non‑STEMI).

Not a fit: Patients with recent STEMI (within 3 days), left‑main disease, very small vessels (<2.0 mm), or other protocol exclusion criteria are unlikely to benefit from the tested approaches.

Why it matters

Potential benefit: If successful, this approach could reduce the need for permanent stents and lower rates of restenosis and repeat procedures in bifurcation lesions.

How similar studies have performed: Paclitaxel DCBs and drug‑eluting stents have shown benefit in settings such as in‑stent restenosis and small‑vessel disease, but randomized data for DCB use in native bifurcation lesions—especially with newer sirolimus‑coated balloons—remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Milan and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Coronary Artery DiseaseDCBCoronary artery diseaseBifurcation coronary lesionsDrug-coated balloons
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.