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

RecruitingNAAges 18 Years - anyAllFundación EPIC
NCT06657833 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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).
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What it tests

  • 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
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Where

15 sites
Leiden University Medical Center
Leiden, Netherlands
Hospital Del Mar
Barcelona, Spain
Hospital Universitario de La Paz
Fuencarral-El Pardo, Spain
Hospital Universitario de Galdakao-Usansolo
Galdakao, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital Universitario de León
León, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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