Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-11

Study Completion Date

2034-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)