DCB vs. DES in Bifurcation Coronary Lesions

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Paclitaxel drug-coated balloons
  Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent
• Устройство Sirolimus drug-coated balloons
  Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent
• Устройство New generation drug-eluting stent
  Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent

Первичные конечные точки

• 6-9 Month CT-FFR or Invasive FFR in Bifurcation Lesions [Срок оценки: 6-9-month]
• 6-9-Month CT-FFR or Invasive FFR: % Max Stenosis (Main + Side Branch) [Срок оценки: 6-9-month]

Вторичные конечные точки (9)

• MACE [Срок оценки: 24 +/- 1 months]
• Cardiac death [Срок оценки: 24+/- 1 months]
• All-cause death [Срок оценки: 24+/- 1 months]
• Q-wave MI [Срок оценки: 24+/- 1 months]
• Any MI [Срок оценки: 24+/- 1 months]
• TLR [Срок оценки: 24+/- 1 months]
• TVR [Срок оценки: 24+/- 1 months]
• Vessel thrombosis [Срок оценки: 24+/- 1 months]
• Bleedings following BARC classification [Срок оценки: 24+/- 1 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Польша · 13 центров

• First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland — Gdansk
• Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Kat — Katowice
• Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University — Krakow
• Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland — Krakow
• Department of Cardiology, Copper Health Centre (MCZ) — Lubin
• Clinical Department of Interventional Cardiology, Medical University of Lublin — Lublin
• Department of Cardiology, Poznan University of Medical Sciences — Poznan
• Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rz — Rzeszów
• … и ещё 5 центров

Румыния · 2 центра

• Heart Institute, Cluj-Napoca — Cluj-Napoca
• Sibiu County Emergency Clinical Hospital — Sibiu

Италия · 1 центр

• Fondazione Ricerca e Innovazione Cardiovascolare — Milan

Сингапур · 1 центр

• Tan Tock Seng Hospital — Singapore

Идентификаторы

NCT: NCT06551662 · PICCOLETO V

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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