Coronary Artery DiseaseRW-DCBNCT07875088
Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Kristian Rivera at 5 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary Drug-Coated Balloon
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 16 Oct 2026to Nov 2030
- How long will I take part?
- 24 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Lleida, 25198
Kristian Rivera, MD, PhD, 973705273, psrivera.lleida.ics@gencat.cat
psrivera.lleida.ics@gencat.cat
- Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Juan Francisco Oteo Domínguez, MD
- Recruiting
Hospital Universitari Son Espases
Palma de Mallorca, Illes Baleares, 07120
Jaume Maristany Daunert
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Guillermo Sánchez Elvira
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cardiología Ignacio Chávez
Mexico City, Mexico City, 14080
Félix Damas de los Santos, MD
About this study
Official title: Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease: A Multicenter Ambispective Cohort Study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary Drug-Coated Balloon
- Keywords
- Drug-Coated Balloon Angioplasty, Percutaneous Coronary Intervention, In-Stent Restenosis, De Novo Coronary Lesions, Small Vessel Coronary Disease, Acute Coronary Syndrome, Chronic Total Occlusion, Cardiac Allograft Vasculopathy, Lesion Preparation, Real-World Registry
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Drug-Coated BalloonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Coronary DCB Strategy Cohort | 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. Receives: Device: Coronary Drug-Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the index procedure through 12 months
Secondary outcomes (15)
Cardiovascular Death
Time to cardiovascular death according to Drug-Coated Balloon Academic Research Consortium definitions.
Measured: Through 24 months, assessed at 30 days, 6 months, 12 months, and 24 months
All-Cause Death
Time to death from any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the index procedure
Target Vessel Myocardial Infarction
Time to target vessel myocardial infarction according to Drug-Coated Balloon Academic Research Consortium definitions.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the index procedure (periprocedural)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start16 Oct 2026
- Primary completionNov 2029 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Kristian Rivera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristian Rivera, Hospital Arnau de Vilanova
- Investigators
- Kristian Rivera, MD, PhD, Principal investigator, Hospital Universitari Arnau de Vilanova de LleidaPaula Vela Martín, MD, Principal investigator, Hospital Universitari Arnau de Vilanova de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875088
- Sponsor's protocol ID
- RW-DCB-PR-002
- Other IDs
- CEIC-3552
- Acronym
- RW-DCB
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.