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

Launched by FUNDACIÓN EPIC · Oct 23, 2024

Keywords

ClinConnect Summary

The DEBSCAN-IVL trial is studying two different treatments for patients with coronary artery disease who have specific blockages in their heart arteries known as calcified nodules. These treatments are a drug-eluting balloon (DEB) and a drug-eluting stent (DES). The goal of the trial is to see which treatment works better for these patients and to help doctors decide the best approach for managing this condition.

To be eligible for the trial, participants must be over 18 years old and have stable coronary artery disease or acute coronary syndromes that require a procedure called percutaneous coronary intervention (PCI). They need to have a severe blockage in a heart artery that is between 2.5 and 4 mm wide, confirmed through special imaging tests. Participants can expect to be randomly assigned to receive either the drug-eluting balloon or the drug-eluting stent, and will need to follow up with their doctors to monitor their progress. It's important to note that some patients, such as those who are pregnant, have life-threatening conditions, or have previously received similar treatments, may not be eligible to participate.

Gender

ALL

Eligibility criteria

• 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 a calcified nodule (highly recommended confirmation 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 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).