Actively Recruiting
DCB vs. DES in Bifurcation Coronary Lesions
Led by Fondazione Ricerca e Innovazione Cardiovascolare ETS · Updated on 2025-12-04
321
Participants Needed
17
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DCB vs. DES in Bifurcation Coronary Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of silent ischemia, stable or unstable angina, or acute myocardial infarction older than 1 week from chest pain onset
- Understands the trial design and provides written informed consent
- Willingness to comply with all follow-up evaluations
- Target lesion is a native non-left main bifurcation coronary artery lesion
- Target lesion classified as Medina 0,1,1; 1,0,1; 1,1,1; or 0,0,1 eligible for PCI
- Target lesion reference vessel diameter at least 2.0 mm by visual estimation
- Target lesion has at least 50% stenosis by visual estimation
- Side branch lesion length less than 25 mm by visual estimation
You will not qualify if you...
- STEMI within 3 days from chest pain onset to coronary angiography
- Known allergy to study balloon or stent system
- Serious medical illness reducing life expectancy to less than 12 months
- Pregnant or nursing
- Participation in another clinical trial without primary endpoint reached within 24 months after index procedure
- Planned procedure that may cause protocol non-compliance or confound data
- In-stent restenosis lesion
- Chronic total occlusion lesion in main vessel or side branch
- Left ventricular ejection fraction less than 30%
- Visible and untreatable thrombus at lesion site
- Severe or more than 270° calcification of target vessel including proximal lesion
- Bifurcation lesion where stent strategy is anticipated
- Left main stem stenosis greater than 50%
- Target lesion in left main stem
- Lesion length greater than 50 mm in main vessel
- Lesion length greater than 25 mm in side branch
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Fondazione Ricerca e Innovazione Cardiovascolare
Milan, Italy
Not Yet Recruiting
2
First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
Gdansk, Poland
Not Yet Recruiting
3
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Katowice, Poland, 40-635
Not Yet Recruiting
4
Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland
Krakow, Poland
Not Yet Recruiting
5
Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
Krakow, Poland
Not Yet Recruiting
6
Department of Cardiology, Copper Health Centre (MCZ)
Lubin, Poland
Not Yet Recruiting
7
Clinical Department of Interventional Cardiology, Medical University of Lublin
Lublin, Poland
Not Yet Recruiting
8
Department of Cardiology, Poznan University of Medical Sciences
Poznan, Poland
Not Yet Recruiting
9
Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow
Rzeszów, Poland
Not Yet Recruiting
10
Department of Cardiology and Internal Diseases, Military Institute of Medicine
Warsaw, Poland
Not Yet Recruiting
11
Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration
Warsaw, Poland
Not Yet Recruiting
12
Department of Cardiology
Wałbrzych, Poland
Not Yet Recruiting
13
Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University
Wroclaw, Poland
Not Yet Recruiting
14
Third Department of Cardiology, Medical University of Katowice
Zabrze, Poland
Not Yet Recruiting
15
Heart Institute, Cluj-Napoca
Cluj-Napoca, Romania
Actively Recruiting
16
Sibiu County Emergency Clinical Hospital
Sibiu, Romania
Actively Recruiting
17
Tan Tock Seng Hospital
Singapore, Singapore
Not Yet Recruiting
Research Team
B
Bernardo Cortese
CONTACT
W
Wojciech Wańha
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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