Drug-coated Balloon Registry for De Novo Coronary Artery Disease
Official title: ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)
Run by Emory University · NCT07559903 · Data updated 2026-11-12
This registry tests how drug-coated balloons perform in adults undergoing PCI for new coronary artery disease across multiple international centers.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Emory University Academic / other |
| Locations | 19 sites (Phoenix, Arizona and 18 other locations) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | May 2031 |
| Study ends | May 2031 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07559903 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18 years and older) undergoing PCI for de novo coronary artery disease with a drug-coated balloon at participating centers.
✕Probably not a fit
Patients not receiving a DCB or those undergoing PCI for non-de novo lesions may not experience direct benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, international registry collecting long-term data on patients treated with drug-coated balloons during PCI for de novo coronary artery disease. Data are gathered from multiple centers with Emory University as the coordinating center, using a centralized REDCap database. Treatments, including the choice of DCB and accompanying techniques, are at the treating physician's discretion and reflect standard care. The study aims to describe real-world outcomes such as safety and angiographic results over time. Participation is limited to adults undergoing PCI with a DCB for de novo lesions at participating institutions.
Why it matters
Potential benefit: If successful, the registry could clarify real-world safety and effectiveness of DCBs in de novo CAD and guide future clinical practice.
How similar studies have gone: Prior studies with DCBs have shown favorable real-world outcomes, but this registry focuses on prospective, multicenter, international data collection for de novo lesions.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Emory University Hospital Midtown
Atlanta, Georgia, United States Recruiting -
Emory University Hospital
Atlanta, Georgia, United States Recruiting -
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States Recruiting -
Emory Johns Creek Hospital
Johns Creek, Georgia, United States Recruiting -
Banner University Medical Center
Phoenix, Arizona, United States Not yet recruiting -
Holy Cross Health Fort Lauderdale
Fort Lauderdale, Florida, United States Not yet recruiting
Show 13 more locations
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Tufts Medical Center
Boston, Massachusetts, United States Not yet recruiting -
Brigham and Women's Hospital
Boston, Massachusetts, United States Not yet recruiting -
Allina Health Minneapolis Heart Institute
Minneapolis, Minnesota, United States Not yet recruiting -
The Mount Sinai Hospital
New York, New York, United States Not yet recruiting -
New York-Presbyterian/Weill Cornell Medical Center
New York, New York, United States Not yet recruiting -
Montefiore Medical Center
New York, New York, United States Not yet recruiting -
St. Francis Hospital & Heart Center
Roslyn, New York, United States Not yet recruiting -
Sanger Heart & Vascular Institute
Charlotte, North Carolina, United States Not yet recruiting -
Duke University Hospital
Durham, North Carolina, United States Not yet recruiting -
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States Not yet recruiting -
Vanderbilt University Medical Center
Nashville, Tennessee, United States Not yet recruiting -
Universitatsklinikum des Saarlandes
Homberg (Efze), Germany Not yet recruiting -
University Clinical Centre of Serbia
Belgrade, Serbia Not yet recruiting
Study contacts
- Principal investigator: Pratik Sandesara, MD — Emory University
- Study coordinator: Daniel Gold, MD
- Email: daniel.alexander.gold@emory.edu
- Phone: 314-761-3396
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.