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NCT07231835Recruiting

Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons

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

Source: ClinicalTrials.gov · Last updated 17 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
3000 (estimated)
First submitted
14 Nov 2025
Start date
11 Nov 2025
Primary completion date
30 Sept 2029
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
NCT number
NCT07231835

What you commit to

  • Study type: Observational
  • Planned participants: 3000
  • From 11 Nov 2025 to the primary completion date, 30 Sept 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Allergy to paclitaxel

Other

  • Inability to provide informed consent

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Amsterdam UMC
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.