Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons (RECORD-DCB)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Enrolling

Conditions: Stable Coronary Artery Disease (CAD), Myocardial Infarction; ACS (Acute Coronary Syndrome); Drug Coated Balloon; Paclitaxel; CAD - Coronary Artery Disease; Percutaneous Coronary Intervention (PCI)

Study type: Observational

Funder types: Other

Identifiers

NCT07231835

2025.0981

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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