Tests two treatments for narrowed heart arteries with calcified nodules
Compares drug balloons and drug stents after lithotripsy in adults with coronary artery disease.
Plain-language title generated from the registry record
Registry title: DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
Key facts
- Where
- Leiden, NetherlandsSee the site
Where in Netherlands
- Leiden University Medical CenterLeiden, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación EPIC
- Trial code
- NCT06657833
- Record updated
- 30 September 2026
- Original description
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).Read full original descriptionShow less
DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
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).
Inclusion: 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: Target lesion previously treated with stents or DEB; Cardiogenic Shock or Cardiac arrest at the moment of the index procedure; 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; Impossibility to maintain double antiplatelet treatment during at least 1 month; Life expectancy <1 year; Index lesion at left main stem; Aorto-ostial lesion; High thrombus burden in the target lesion (TIMI thrombus scale≥3).