NCT06551662

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
21mo left

Started Aug 2025

Geographic Reach
4 countries

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Aug 2025Feb 2028

First Submitted

Initial submission to the registry

July 30, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
12 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Expected
Last Updated

December 4, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

July 30, 2024

Last Update Submit

November 27, 2025

Conditions

DCBCoronary Artery Disease

Keywords

Coronary artery diseaseBifurcation coronary lesionsDrug-coated balloons

Outcome Measures

Primary Outcomes (2)

  • 6-9 Month CT-FFR or Invasive FFR in Bifurcation Lesions

    6-9-month CT-scan FFR (core lab) * 6-9-month Main vessel CT-FFR * 6-9-month Side branch CT-FFR or If invasive coronary angiography indicated at 6-9 months: * invasive FFR of Main vessel * invasive FFR of Side branch

    6-9-month

  • 6-9-Month CT-FFR or Invasive FFR: % Max Stenosis (Main + Side Branch)

    6-9-month CT-scan FFR (core lab): * Main vessel % maximum stenosis * Side branch % maximum stenosis or If invasive coronary angiography indicated at 6-9 months: * Main vessel % maximum stenosis * Side branch % maximum stenosis

    6-9-month

Secondary Outcomes (9)

  • MACE

    24 +/- 1 months

  • Cardiac death

    24+/- 1 months

  • All-cause death

    24+/- 1 months

  • Q-wave MI

    24+/- 1 months

  • Any MI

    24+/- 1 months

  • +4 more secondary outcomes

Study Arms (3)

Device: Paclitaxel drug-coated-balloons

EXPERIMENTAL
Device: Paclitaxel drug-coated balloons

Device: Sirolimus drug-coated-balloons

EXPERIMENTAL
Device: Sirolimus drug-coated balloons

Device: new generation drug-eluting-stents

ACTIVE COMPARATOR
Device: New generation drug-eluting stent

Interventions

New generation drug-eluting stentDEVICE

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

Device: new generation drug-eluting-stents
Paclitaxel drug-coated balloonsDEVICE

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

Device: Paclitaxel drug-coated-balloons
Sirolimus drug-coated balloonsDEVICE

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

Device: Sirolimus drug-coated-balloons

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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.

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Fondazione Ricerca e Innovazione Cardiovascolare

Milan, Italy

NOT YET RECRUITING

First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland

Gdansk, Poland

NOT YET RECRUITING

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

Katowice, 40-635, Poland

NOT YET RECRUITING

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

Krakow, Poland

NOT YET RECRUITING

Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland

Krakow, Poland

NOT YET RECRUITING

Department of Cardiology, Copper Health Centre (MCZ)

Lubin, Poland

NOT YET RECRUITING

Clinical Department of Interventional Cardiology, Medical University of Lublin

Lublin, Poland

NOT YET RECRUITING

Department of Cardiology, Poznan University of Medical Sciences

Poznan, Poland

NOT YET RECRUITING

Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow

Rzeszów, Poland

NOT YET RECRUITING

Department of Cardiology and Internal Diseases, Military Institute of Medicine

Warsaw, Poland

NOT YET RECRUITING

Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration

Warsaw, Poland

NOT YET RECRUITING

Department of Cardiology

Wałbrzych, Poland

NOT YET RECRUITING

Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University

Wroclaw, Poland

NOT YET RECRUITING

Third Department of Cardiology, Medical University of Katowice

Zabrze, Poland

NOT YET RECRUITING

Heart Institute, Cluj-Napoca

Cluj-Napoca, Romania

RECRUITING

Sibiu County Emergency Clinical Hospital

Sibiu, Romania

RECRUITING

Tan Tock Seng Hospital

Singapore, Singapore

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Bernardo Cortese

CONTACT

504827636bcortese@gmail.com

Wojciech Wańha

CONTACT

504827636wojciech.wanha@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 13, 2024

Study Start

August 1, 2025

Primary Completion

February 1, 2026

Study Completion (Estimated)

February 1, 2028

Last Updated

December 4, 2025

Record last verified: 2025-09

Locations

PL(13)SG(1)RO(2)IT(1)