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NCT06657833Recruiting

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

Source: ClinicalTrials.gov · Last updated 30 Sept 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
128 (estimated)
First submitted
21 Oct 2024
Start date
17 Dec 2024
Primary completion date
30 Oct 2027
Lead sponsor
Fundación EPIC
NCT number
NCT06657833

What you commit to

  • Study type: Interventional
  • Planned participants: 128
  • From 17 Dec 2024 to the primary completion date, 30 Oct 2027
  • 15 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Target lesion previously treated with stents or DEB.

Other illness

  • Cardiogenic Shock or Cardiac arrest at the moment of the index procedure.

Other

  • 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).

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Universitario de La Paz
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Fuencarral-El PardoSpainRecruiting
Hospital Universitario de Galdakao-Usansolo
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GaldakaoSpainRecruiting
Hospital Universitario De Leon
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LeónSpainRecruiting
Hospital Universitari de Bellvitge
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario Puerta de Hierro
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Clínico San Carlos
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Moncloa-AravacaSpainRecruiting
Hospital Universitario de Navarra
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PamplonaSpainRecruiting
Hospital General Universitario de Valencia
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ValenciaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Hospital Clínico Universitario de Valladolid
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ValladolidSpainRecruiting
Hospital Universitario de Vigo
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VigoSpainRecruiting
Hospital Universitario Miguel Servet
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ZaragozaSpainRecruiting
Leiden University Medical Center
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LeidenNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.