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

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

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).

Conditions2

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