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