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NCT07559903Recruiting

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

Emory University

Start Date

6/1/2026

Completion Date

5/1/2031

Summary

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.

Detailed 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 Criteria

Age Range: 18 years to No maximum

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

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Conditions

Coronary Artery Disease

Locations

Banner University Medical Center

Phoenix, Arizona 85006

United States

Holy Cross Health Fort Lauderdale

Fort Lauderdale, Florida 33308

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

Emory Saint Joseph's Hospital

Atlanta, Georgia 30342

United States

Emory Johns Creek Hospital

Johns Creek, Georgia 30097

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Allina Health Minneapolis Heart Institute

Minneapolis, Minnesota 55407

United States

The Mount Sinai Hospital

New York, New York 10029

United States

New York-Presbyterian/Weill Cornell Medical Center

New York, New York 10065

United States

Montefiore Medical Center

New York, New York 10467

United States

St. Francis Hospital & Heart Center

Roslyn, New York 11576

United States

Sanger Heart & Vascular Institute

Charlotte, North Carolina 28203

United States

Duke University Hospital

Durham, North Carolina 27707

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Universitatsklinikum des Saarlandes

Homberg (Efze),

Germany

University Clinical Centre of Serbia

Belgrade,

Serbia