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ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)

ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)

Recruiting
18 years and older
All
Phase N/A

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Overview

The primary objective of this protocol is to develop a comprehensive, multicenter international prospective registry to capture long-term clinical outcomes for adult patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) for de novo coronary artery disease.

Description

This database is designed as a prospective, international multi-center registry. The project aims to collect longitudinal data to evaluate the clinical performance of drug-coated balloons (DCB) in adult patients undergoing percutaneous coronary intervention (PCI) for de novo coronary artery disease. Emory will serve as the data coordinating center. All the participating sites will input information into Emory-hosted Redcap database. Data use agreements will be executed between Emory and each participating institution prior to data entry.

As a prospective registry, all clinical interventions, including the choice of DCB, vessel preparation techniques, and adjunct pharmacotherapy, are performed at the discretion of the treating physician according to the standard of care; no experimental interventions are mandated by this protocol.

Eligibility

Inclusion Criteria:

  • All adult patients (≥ 18 years of age) undergoing PCI for de novo CAD using DCB

Exclusion Criteria:

  • Patients under the age of 18; PCI procedures without the utilization of DCB; PCI procedures for non de novo lesions

Study details
    Coronary Artery Disease

NCT07559903

Emory University

27 June 2026

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