Status:
RECRUITING
DCB vs. DES in Bifurcation Coronary Lesions
Lead Sponsor:
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Conditions:
Coronary Artery Disease
DCB
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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)
- 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
- 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)
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT06551662
Start Date
August 1 2025
End Date
February 1 2028
Last Update
December 4 2025
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Fondazione Ricerca e Innovazione Cardiovascolare
Milan, Italy
2
First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
Gdansk, Poland
3
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Katowice, Poland, 40-635
4
Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland
Krakow, Poland