About this trial
International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting stents (DES).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon
- Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent