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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The RW-DCB is an investigator-led, multicenter observational registry collecting real-world data on the use of drug-coated balloons during percutaneous coronary intervention. It includes consecutive adults where a DCB strategy is planned or attempted, regardless of presentation or lesion type, and regardless of whether the procedure is completed as planned. Data will capture the full intended DCB strategy, including cases where delivery fails, bailouts occur, or strategy changes to another device or therapy are made. Information is collected retrospectively for procedures from 2022 onward and prospectively at each site, using a pseudonymized patient identifier to link procedures, lesions, devices, and follow-up. The study aims to describe the practicality and limitations of DCB use in an all-comer population, including planned hybrid treatments and bailout scenarios.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto Nacional de Cardiología Ignacio Chávez
  Mexico City, Mexico City, Mexico Recruiting
• Hospital Universitari Son Espases
  Palma de Mallorca, Illes Baleares, Spain Recruiting
• Hospital Universitari Arnau de Vilanova de Lleida
  Lleida, Lleida, Spain Recruiting
• Hospital Universitario Puerta de Hierro Majadahonda
  Majadahonda, Madrid, Spain Recruiting
• Hospital Universitario de Navarra
  Pamplona, Navarre, Spain Recruiting

Study contacts

• Principal investigator: Kristian Rivera, MD, PhD — Hospital Universitari Arnau de Vilanova de Lleida
• Study coordinator: Kristian Rivera, MD, PhD
• Email: psrivera.lleida.ics@gencat.cat
• Phone: 973705273

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.