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

November 14, 2025 updated by: Bimmer Claessen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

RECORD-DCB: 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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults (>18 years) with stable CAD or ACS who have a PCI indication and are treated with the Protégé DCB.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From enrollment to 1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2025

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2034

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025.0981

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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