Clinical trial NCT06551662: DCB vs. DES in Bifurcation Coronary Lesions
Official title: Drug-coated Balloons vs. Drug Eluting Stents in Bifurcation Coronary Lesions: PICCOLETO V Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
DCB
Keywords: Coronary artery disease
Bifurcation coronary lesions
Drug-coated balloons
Lead sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 true 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)

Primary outcomes:
measure: CT-scan FFR (Core lab) • Main vessel CT-FFR • Side branch CT-FFR
timeFrame: 9-month
measure: CT-scan FFR (Core lab) • Main vessel % maximum stenosis • Side branch % maximum stenosis
timeFrame: 9-month
Secondary outcomes:
measure: MACE
timeFrame: 24 +/- 1 months
measure: Cardiac death
timeFrame: 24+/- 1 months
measure: All-cause death
timeFrame: 24+/- 1 months
measure: Q-wave MI
timeFrame: 24+/- 1 months
measure: Any MI
timeFrame: 24+/- 1 months
measure: TLR
timeFrame: 24+/- 1 months
measure: TVR
timeFrame: 24+/- 1 months
measure: Vessel thrombosis
timeFrame: 24+/- 1 months
measure: Bleedings following BARC classification
timeFrame: 24+/- 1 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione Ricerca e Innovazione Cardiovascolare
city: Gdańsk
country: Poland
facility: First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
city: Katowice
country: Poland
facility: Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
city: Kraków
country: Poland
facility: Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland
city: Kraków
country: Poland
facility: Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
city: Lubin
country: Poland
facility: Department of Cardiology, Copper Health Centre (MCZ)
city: Lublin
country: Poland
facility: Clinical Department of Interventional Cardiology, Medical University of Lublin
city: Poznań
country: Poland
facility: Department of Cardiology, Poznan University of Medical Sciences
city: Rzeszów
country: Poland
facility: Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow
city: Warsaw
country: Poland
facility: Department of Cardiology and Internal Diseases, Military Institute of Medicine
city: Warszawa
country: Poland
facility: Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration
city: Wałbrzych
country: Poland
facility: Department of Cardiology
city: Wrocław
country: Poland
facility: Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University
city: Zabrze
country: Poland
facility: Third Department of Cardiology, Medical University of Katowice
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
References: