Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability to provide informed consent

Allergy to paclitaxel

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

TLF at 1 year

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)

Time frame
From enrollment to 1 year follow-up

Secondary outcomes

Other outcomes

Sponsors and contacts

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