Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07231835

Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Percutaneous Coronary Intervention (PCI) ACS (Acute Coronary Syndrome) Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis CAD - Coronary Artery Disease Cardiovascular Diseases Coronary Artery Disease Coronary Disease Drug Coated Balloon Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Paclitaxel Pathologic Processes Pathological Conditions, Signs and Symptoms Stable Coronary Artery Disease (CAD), Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. TLF at 1 year

    Time frame: From enrollment to 1 year follow-up

    Target Lesion Failure (TLF) at 1 year, defined as a composite of:

    • Cardiovascular death
    • Target vessel myocardial infarction (TV-MI)
    • Clinically driven target lesion revascularization (TLR)

Study contacts

Contact information is provided by the study sponsor or research team.

Inge T Bosch

CONTACT

[email protected]

+31205663884

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: RECORD-DCB

Important dates

Study start
2025
Primary completion
2029
Study completion
2034
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.