DCB vs. DES in Bifurcation Coronary Lesions

Launched by FONDAZIONE RICERCA E INNOVAZIONE CARDIOVASCOLARE ETS · Aug 9, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing two different types of treatments for patients with a specific type of heart condition called bifurcation coronary artery disease, which occurs when a blood vessel splits into two branches. The study will look at the effectiveness of a special type of balloon (DCB) and a type of stent (DES) in helping to open up these narrowed blood vessels. Participants will be randomly assigned to one of three treatment groups after their condition has been evaluated, and all patients will receive standard care as part of the study.

To be eligible for this trial, participants must be at least 18 years old and have symptoms like chest pain or have recently experienced a heart attack. The targeted blood vessel must have a blockage of at least 50% and meet specific measurements. Before joining, patients will receive detailed information about the study and will need to provide written consent. Throughout the study, participants can expect to undergo a procedure to open their blocked blood vessels, with careful monitoring to ensure their safety and health. It’s important to note that certain individuals, such as those with severe heart conditions or who are pregnant, will not be eligible to participate.

Gender

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Eligibility criteria

• 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)