Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Percutaneous Coronary Intervention (PCI), Drug Coated Balloon, Paclitaxel, CAD - Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
RECORD-DCB: Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons
Overview
The primary aim of this registry is to systematically collect and analyze real-world data on all patients undergoing PCI with the Protégé paclitaxel-eluting DCB to evaluate procedural outcomes, long-term efficacy, and safety across various clinical indications. This registry aims to assess the clinical effectiveness of DCB therapy across diverse patient populations, including those with stable coronary artery disease (CAD) and acute coronary syndromes (ACS), as well as various lesion subsets, encompassing (but not limited to) in-stent restenosis (ISR), de novo coronary lesions, small vessel disease, bifurcation and calcified lesions, coronary bypass graft lesions, and patients at high risk of bleeding. Additionally, the study aims to identify predictors of success, complications, and optimal treatment strategies to further refine the use of DCBs.
Primary outcome measures
- TLF at 1 year [Time frame: From enrollment to 1 year follow-up]
Eligibility criteria
Inclusion criteria
- Patients undergoing PCI with the Protégé paclitaxel-eluting DCB
- Age ≥ 18 years
- Presence of a de novo lesion or in-stent restenosis in a native coronary artery or a in a bypass graft and suitable for PCI
- Reference vessel diameter between 2.0 - 4.5 mm
- Patient suitable for dual antiplatelet therapy (DAPT)
Exclusion criteria
- Inability to provide informed consent
- Allergy to paclitaxel
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Amsterdam UMC — Amsterdam
Identifiers
NCT: NCT07231835 · 2025.0981