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Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons

NCT07231835 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2025-11-17

No results posted yet for this study

Summary

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.

Conditions

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

Sponsors & Collaborators

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

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-11
Primary Completion
2029-09-30
Completion
2034-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07231835 on ClinicalTrials.gov