An observational study in Coronary Artery Disease, sponsored by Kristian Rivera. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Kristian Rivera · Observational
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 prospective data collection begins at each participating center. Prospective enrollment will continue for at least 24 months after activation of the first center. Each participant will be followed for up to 24 months after the index procedure.
The primary outcome is target lesion failure at 12 months, defined as cardiovascular death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. The registry will also evaluate procedural outcomes, DCB delivery failure, changes in treatment strategy, bailout stenting, other clinical events, antithrombotic treatment, and outcomes associated with lesion preparation and specific DCB platforms. The operational target is at least 2,000 participants, with no upper enrollment limit.
Drug-coated balloon angioplasty is increasingly used across a broad range of coronary anatomies and clinical presentations. However, much of the available evidence comes from selected populations, indication-specific cohorts, or studies that include only patients after successful lesion preparation or successful DCB delivery. Such designs may underestimate device delivery failure, changes in the intended strategy, bailout stenting, and other procedural limitations.
RW-DCB is designed to evaluate the complete intended coronary DCB strategy in an all-comer population. Patients will remain eligible when the selected DCB cannot cross the lesion, cannot be delivered, or cannot be inflated, and when the strategy subsequently changes to another DCB, drug-eluting stent implantation, surgery, or medical therapy. Planned hybrid treatment will be distinguished from unplanned bailout treatment.
The first eligible procedure for each participant will be the patient-level index procedure. All lesions treated or evaluated during that procedure will be recorded and classified according to their relationship with the intended DCB strategy. Subsequent coronary procedures, including treatment of a new culprit lesion with another DCB, will remain linked to the same participant and will not create a new patient-level index procedure.
Data will be collected using a pseudonymized patient identifier with linked information for procedures, lesions, DCB devices, follow-up assessments, and clinical events. The registry will capture clinical presentation, lesion indication and anatomical characteristics, lesion preparation, the immediate post-preparation result, exact DCB platform and dimensions, delivery and inflation outcomes, final PCI strategy, procedural complications, and antiplatelet and anticoagulant treatment. No protocol-mandated angiographic follow-up is required.
The primary endpoint is time to first target lesion failure through 12 months after the index procedure. Target lesion failure comprises cardiovascular death, target vessel myocardial infarction, or clinically indicated target lesion revascularization according to Drug-Coated Balloon Academic Research Consortium definitions. Secondary outcomes will include the individual components of the primary endpoint, all-cause death, any myocardial infarction, stroke, any coronary revascularization, hospitalization for heart failure, lesion thrombosis, bleeding, device and procedural success, delivery failure, bailout stenting, and other procedural complications. Outcomes will be assessed at discharge, 30 days, 6 months, 12 months, and 24 months.
Prespecified analyses will evaluate outcomes according to the intended DCB strategy, treatment ultimately received, lesion indication, clinical and anatomical modifiers, lesion preparation, specific DCB platform, center, operator experience, and calendar period. Additional analyses will examine cardiac allograft vasculopathy and repeated coronary procedures. Comparisons between specific DCB platforms will be performed only when sample size, event count, covariate completeness, and overlap between treatment groups are sufficient.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →This is the only study on the registry with Kristian Rivera as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Consecutive adults undergoing percutaneous coronary intervention at participating centers during each center's defined study period, in whom a coronary drug-coated balloon strategy is attempted for at least one native epicardial coronary artery or coronary bypass graft lesion. The registry includes all clinical presentations and coronary lesion types. The first eligible procedure is designated as the patient-level index procedure. Patients remain eligible if the intended drug-coated balloon cannot cross the lesion, cannot be delivered or inflated, or the strategy changes to another drug-coated balloon, drug-eluting stent implantation, surgery, or medical therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Failure to deliver or inflate the intended drug-coated balloon, crossover to another treatment strategy, and incomplete follow-up are not exclusion criteria.
Consecutive adults undergoing percutaneous coronary intervention at participating centers in whom a coronary drug-coated balloon strategy is attempted for at least one native coronary artery or coronary bypass graft lesion. Patients remain in the cohort regardless of clinical presentation, lesion type, DCB platform, delivery or inflation success, or final treatment strategy, including crossover to another DCB, drug-eluting stent implantation, coronary artery bypass grafting, or medical therapy.
Device: Coronary Drug-Coated Balloon
The exposure of interest is an intended coronary drug-coated balloon strategy during percutaneous coronary intervention using any commercially available DCB platform. Treatment is not assigned by the registry. Device selection, lesion preparation, adjunctive imaging, antithrombotic therapy, and the final treatment strategy are determined by the treating team. Attempted strategies remain included when the DCB cannot cross the lesion, cannot be delivered, or cannot be inflated, including subsequent crossover or bailout stenting.
Target Lesion Failure
Time to first occurrence of target lesion failure, defined as the composite of cardiovascular death, target vessel myocardial infarction, or clinically indicated target lesion revascularization according to Drug-Coated Balloon Academic Research Consortium definitions.
Time frame: From the index procedure through 12 months
Cardiovascular Death
Time to cardiovascular death according to Drug-Coated Balloon Academic Research Consortium definitions.
Time frame: Through 24 months, assessed at 30 days, 6 months, 12 months, and 24 months
All-Cause Death
Time to death from any cause.
Time frame: Through 24 months, assessed at 30 days, 6 months, 12 months, and 24 months
Patient-Oriented Composite Endpoint
Time to first occurrence of all-cause death, any stroke, any myocardial infarction, or any coronary revascularization.
Time frame: Through 24 months, assessed at 30 days, 6 months, 12 months, and 24 months
Bleeding Events
Occurrence of bleeding events classified according to Bleeding Academic Research Consortium criteria and analyzed by bleeding type and severity.
Time frame: From the index procedure through 24 months
Device Success
Number and proportion of attempted drug-coated balloon devices with successful delivery to the intended target lesion, inflation, and withdrawal, with final residual diameter stenosis below 40% by site assessment.
Time frame: During the index procedure
Intended Drug-Coated Balloon Strategy Failure
Number and proportion of index lesions in which the intended drug-coated balloon strategy was not completed because no drug-coated balloon could be delivered or inflated, treatment crossed over to a drug-eluting stent, surgery, or medical therapy, or unplanned bailout stenting was required. Substitution with another drug-coated balloon followed by successful drug-coated balloon treatment will be classified as failure of the initially selected device, but not as strategy failure.
Time frame: During the index procedure
Target Vessel Myocardial Infarction
Time to target vessel myocardial infarction according to Drug-Coated Balloon Academic Research Consortium definitions.
Time frame: Through 24 months, assessed at 30 days, 6 months, 12 months, and 24 months
Clinically Indicated Target Lesion Revascularization
Time to clinically indicated target lesion revascularization according to Drug-Coated Balloon Academic Research Consortium definitions.
Time frame: Through 24 months, assessed at 30 days, 6 months, 12 months, and 24 months
Any Myocardial Infarction
Time to first myocardial infarction, irrespective of its relationship to the target vessel, according to Drug-Coated Balloon Academic Research Consortium definitions.
Time frame: Through 24 months, assessed at 30 days, 6 months, 12 months, and 24 months
Target Vessel Revascularization
Time to first repeat revascularization of any segment of the target vessel, including the target lesion.
Time frame: Through 24 months, assessed at 30 days, 6 months, 12 months, and 24 months
Any Coronary Revascularization
Time to first repeat coronary revascularization by percutaneous coronary intervention or coronary artery bypass grafting, irrespective of the treated vessel or lesion.
Time frame: Through 24 months, assessed at 30 days, 6 months, 12 months, and 24 months
Stroke
Time to first ischemic, hemorrhagic, or undetermined stroke documented during follow-up.
Time frame: Through 24 months, assessed at 30 days, 6 months, 12 months, and 24 months
Target Lesion Thrombosis
Time to first definite or probable target lesion thrombosis according to Drug-Coated Balloon Academic Research Consortium definitions.
Time frame: Through 24 months, assessed at 30 days, 6 months, 12 months, and 24 months
Procedural Success
Number and proportion of index procedures with successful drug-coated balloon treatment of every lesion for which a drug-coated balloon strategy was intended, without in-hospital cardiovascular death, clinically indicated target lesion revascularization, periprocedural myocardial infarction, stroke, Bleeding Academic Research Consortium type 3 or 5 bleeding, or unplanned bailout stenting. Planned hybrid stenting will not be classified as procedural failure.
Time frame: From the index procedure through hospital discharge, assessed up to 30 days
Procedural Complications
Number and proportion of index lesions with coronary dissection, acute recoil, acute vessel closure, coronary perforation, or no-reflow, reported separately by complication type.
Time frame: During the index procedure (periprocedural)
Number of Participants by Antithrombotic Treatment Regimen
Number and proportion of participants receiving each antiplatelet and anticoagulant treatment regimen, described according to clinical presentation and final percutaneous coronary intervention strategy.
Time frame: At hospital discharge, assessed up to 30 days after the index procedure, and at 30 days, 6 months, 12 months, and 24 months after the index procedure
Planned Duration of Antithrombotic Treatment
Planned duration, in months, of antiplatelet and anticoagulant treatment prescribed after the index procedure, described according to clinical presentation and final percutaneous coronary intervention strategy.
Time frame: At hospital discharge, assessed up to 30 days after the index procedure
Actual Duration of Antithrombotic Treatment
Actual duration, in months, of antiplatelet and anticoagulant treatment received during follow-up, described according to clinical presentation and final percutaneous coronary intervention strategy.
Time frame: Through 24 months after the index procedure
Plan to share: No — Individual participant data will not be made publicly available because the registry includes multicenter pseudonymized clinical data governed by institutional approvals, data protection requirements, and data sharing agreements. Study results will be reported in aggregate. Any future request for access to deidentified data would require separate review and approval by the coordinating investigators, participating centers, and relevant ethics and data protection authorities, as applicable.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.