Clinical trial Recruiting at 4 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment5000 (estimated)
SponsorEmory University
Academic / other
Locations19 sites (Phoenix, Arizona and 18 other locations)
StatusRecruiting
StartedJuly 1, 2026
Main results expectedMay 2031
Study endsMay 2031
Registry record updatedOctober 5, 2026
Trial IDNCT07559903 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.