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Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease

Recruitingn/aAges 18 Years - anyAllKristian Rivera
NCT07875088 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The Real-World Drug-Coated Balloon Registry (RW-DCB) is an investigator-initiated, multicenter, observational cohort study evaluating the use of drug-coated balloons (DCBs) during percutaneous coronary intervention (PCI) in routine clinical practice. The registry will include consecutive adults in whom a coronary DCB strategy is planned or attempted, regardless of the clinical presentation, lesion type, DCB platform, success of lesion preparation, successful delivery of the DCB, or final treatment strategy. The study does not assign any treatment or require additional procedures, tests, or visits. All clinical decisions, including lesion preparation, device selection, use of intracoronary imaging or physiology, antithrombotic therapy, and follow-up, remain at the discretion of the treating team. The retrospective cohort will include eligible procedures performed from January 2022 until

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 years or older at the index procedure. * Percutaneous coronary intervention performed at a participating center during its defined study period, in which at least one coronary drug-coated balloon is selected and introduced into the delivery system with intent to treat an epicardial native coronary lesion or a coronary bypass graft lesion. * Source documentation sufficient to identify the index procedure date, patient, target vessel, and intended drug-coated balloon strategy. * All clinical presentations and coronary lesion types are eligible. Exclusion Criteria: * No coronary drug-coated balloon introduced into the delivery system. * Withdrawal of authorization for prospectively collected data, when applicable. Failure to deliver or inflate the intended drug-coated balloon, crossover to another treatment strategy, and incomplete follow-up are not exclusion criteria.
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What it tests

  • Coronary Drug-Coated Balloon
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Where

5 sites
Instituto Nacional de Cardiología Ignacio Chávez
Mexico City, Mexico
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
Hospital Universitario de Navarra
Pamplona, Spain
🤝 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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