DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.

Regardless some observational data of DEB performance in calcified lesions, there is a lack of data about the safety and efficacy in the setting of calcified nodules. However, a "leave-nothing-behind" PCI strategy is attractive in this scenario in which the probability of non-optimal stent expansion and apposition is higher, hypothesis is, that following optimal plaque modification with IVL, the utilization of a DEB is either non-inferior or possibly superior to DES in terms of late lumen loss and net luminal gain at 6 months follow up.

Inclusion criteria

Patients must meet all inclusion criteria:

• Patients >18 years admitted for stable coronary artery disease or acute coronary syndromes and indication for percutaneous coronary intervention (PCI) and
• Severe coronary lesion with calcified nodule, confirmed with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and;
• Lesion to treat in a vessel between 2.5 and 4 mm.

Exclusion criteria

Patients must not meet any criteria

• Inability to provide oral and written informed consent or unwillingness to come back for systematic angiographic follow-up.
• Pregnant or breastfeeding patients.
• Cardiogenic Shock or Cardiac arrest at the moment of the index procedure.
• Impossibility to maintain double antiplatelet treatment during at least 1 month.
• Life expectancy <1 year.
• Index lesion at left main stem.
• Aorto-ostial lesion.
• Target lesion previously treated with stents or DEB.
• High thrombus burden in the target lesion (TIMI thrombus scale≥3).