DCB vs. DES in Bifurcation Coronary Lesions

Not Applicable

Not yet recruiting

• Conditions: DCB; Coronary Artery Disease
• Interventions: Device: Sirolimus drug-coated balloons; Device: Paclitaxel drug-coated balloons; Device: New generation drug-eluting stent

• Registration Number: NCT06551662
• Lead Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-30
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-09
• Last Update Submitted: 2024-08-09
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13
• Study Start: 2024-09-01
• Primary Completion: 2026-02-01
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 321

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device: Sirolimus drug-coated-balloons	Sirolimus drug-coated balloons	-
Device: Paclitaxel drug-coated-balloons	Paclitaxel drug-coated balloons	-
Device: new generation drug-eluting-stents	New generation drug-eluting stent	-

Primary Outcome Measures

Name	Time	Method
CT-scan FFR (Core lab) • Main vessel CT-FFR • Side branch CT-FFR	9-month	9-month Main vessel CT-FFR
CT-scan FFR (Core lab) • Main vessel % maximum stenosis • Side branch % maximum stenosis	9-month	9-month Side branch CT-FFR

Secondary Outcome Measures

Name	Time	Method
Q-wave MI	24+/- 1 months	Q-wave MI rates at 24+/- 1 months follow-up
TLR	24+/- 1 months	TLR rates at 24+/- 1 months follow-up
TVR	24+/- 1 months	TVR rates at 24+/- 1 months follow-up
Vessel thrombosis	24+/- 1 months	Vessel thrombosis rates at 24+/- 1 months follow-up
MACE	24 +/- 1 months	The MACE was defined as a composite of total mortality, TVR, and spontaneous TV-MI.
Any MI	24+/- 1 months	Any MI rates at 24+/- 1 months follow-up
Bleedings following BARC classification	24+/- 1 months	Bleedings following BARC classification at 24+/- 1 months follow-up
Cardiac death	24+/- 1 months	Cardiac death rates at 24+/- 1 months follow-up
All-cause death	24+/- 1 months	All-cause death rates at 24+/- 1 months follow-up

Trial Locations

Locations (15)

Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University; 🇵🇱 Wrocław, Poland

Fondazione Ricerca e Innovazione Cardiovascolare; 🇮🇹 Milano, Italy

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore

Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland; 🇵🇱 Katowice, Poland

Department of Cardiology, Copper Health Centre (MCZ); 🇵🇱 Lubin, Poland

Clinical Department of Interventional Cardiology, Medical University of Lublin; 🇵🇱 Lublin, Poland

Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration; 🇵🇱 Warszawa, Poland

Department of Cardiology; 🇵🇱 Wałbrzych, Poland

Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland; 🇵🇱 Kraków, Poland

Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow; 🇵🇱 Rzeszów, Poland

Department of Cardiology, Poznan University of Medical Sciences; 🇵🇱 Poznań, Poland

First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland; 🇵🇱 Gdańsk, Poland

Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland; 🇵🇱 Kraków, Poland

Department of Cardiology and Internal Diseases, Military Institute of Medicine; 🇵🇱 Warsaw, Poland

Third Department of Cardiology, Medical University of Katowice; 🇵🇱 Zabrze, Poland