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

NCT07559903 · Emory University
In plain English

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About this study
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
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 design
Enrollment target: 5000 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-06
Estimated completion: 2031-05
Last updated: 2026-06-15
Primary outcomes
  • Incidence of Target Lesion Failure (TLF) (At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge)
  • Mortality and Myocardial Infarction (At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge)
  • Number of any repeat Revascularization (At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge)
Sponsor
Emory University · other
Contacts & investigators
ContactDaniel Gold, MD · contact · daniel.alexander.gold@emory.edu · 314-761-3396
InvestigatorPratik Sandesara, MD · principal_investigator, Emory University
All locations (19)
Banner University Medical CenterNot Yet Recruiting
Phoenix, Arizona, United States
Holy Cross Health Fort LauderdaleNot Yet Recruiting
Fort Lauderdale, Florida, United States
Emory University Hospital MidtownRecruiting
Atlanta, Georgia, United States
Emory University HospitalRecruiting
Atlanta, Georgia, United States
Emory Saint Joseph's HospitalRecruiting
Atlanta, Georgia, United States
Emory Johns Creek HospitalRecruiting
Johns Creek, Georgia, United States
Tufts Medical CenterNot Yet Recruiting
Boston, Massachusetts, United States
Brigham and Women's HospitalNot Yet Recruiting
Boston, Massachusetts, United States
Allina Health Minneapolis Heart InstituteNot Yet Recruiting
Minneapolis, Minnesota, United States
The Mount Sinai HospitalNot Yet Recruiting
New York, New York, United States
New York-Presbyterian/Weill Cornell Medical CenterNot Yet Recruiting
New York, New York, United States
Montefiore Medical CenterNot Yet Recruiting
New York, New York, United States
St. Francis Hospital & Heart CenterNot Yet Recruiting
Roslyn, New York, United States
Sanger Heart & Vascular InstituteNot Yet Recruiting
Charlotte, North Carolina, United States
Duke University HospitalNot Yet Recruiting
Durham, North Carolina, United States
University Hospitals Cleveland Medical CenterNot Yet Recruiting
Cleveland, Ohio, United States
Vanderbilt University Medical CenterNot Yet Recruiting
Nashville, Tennessee, United States
Universitatsklinikum des SaarlandesNot Yet Recruiting
Homberg (Efze), Germany
University Clinical Centre of SerbiaNot Yet Recruiting
Belgrade, Serbia
ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety) · TrialPath