NCT06551662: PICCOLETO V

DCB vs. DES in Bifurcation Coronary Lesions

Recruiting now NA Last updated 4 December 2025

What this trial tests

NA trial testing Paclitaxel drug-coated balloons in Coronary Artery Disease in 321 participants. Currently enrolling.

Timeline

1 August 2025

Primary endpoint
1 February 2026

1 February 2028

Quick facts

Lead sponsor	Fondazione Ricerca e Innovazione Cardiovascolare ETS
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	321
Start date	1 August 2025
Primary completion	1 February 2026
Estimated completion	1 February 2028
Sites	17 locations across Singapore, Italy, Romania, Poland

Drugs / interventions tested

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

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• DCB — all drugs for DCB →

Sponsor

Fondazione Ricerca e Innovazione Cardiovascolare ETS — full company profile →

Who can join

18 and older, any sex, with Coronary Artery Disease or DCB. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.