RecruitingNot ApplicableNCT06657833
DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
Sponsor
Fundación EPIC
Enrollment
128 participants
Start Date
Dec 17, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria10
- 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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Interventions
DEVICEPercutaneous 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 balloon
DEVICEPercutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent
Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT06657833
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