Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07231835

Acronym

RECORD-DCB

Enrollment

3000

Registered

2025-11-17

Start date

2025-11-11

Completion date

2034-09-30

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
TLF at 1 year	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)

Countries

Netherlands

Contacts

Primary ContactInge T Bosch

i.t.bosch@amsterdamumc.nl+31205663884

Outcome results