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Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons

Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons

Recruiting
18 years and older
All
Phase N/A

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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.

Eligibility

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

Study details
    Percutaneous Coronary Intervention (PCI)
    Drug Coated Balloon
    Paclitaxel
    CAD - Coronary Artery Disease
    ACS (Acute Coronary Syndrome)
    Stable Coronary Artery Disease (CAD)
    Myocardial Infarction

NCT07231835

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

31 January 2026

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