NCT06657833 DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
| NCT ID | NCT06657833 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación EPIC |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2027-10-30 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
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
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