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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación EPIC

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

Treatment groups

128 Participants
are divided into 2 treatment groups

Locations

13
Hospital Del Mar08003, Barcelona Spain
Hospital Universitario de La Paz28046, Fuencarral-El Pardo Spain
Hospital Universitario de Galdakao-Usansolo48960, Galdakao Spain
Hospital Universitario de León24008, León Spain

Sponsors and collaborators

Fundación EPIC

Lead sponsor