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

April 24, 2026 updated by: Pratik Sandesara, Emory University
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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Homberg (Efze), Germany
        • Universitätsklinikum des Saarlandes
        • Contact:
          • Bruno Scheller
  • Serbia
      • Belgrade, Serbia
        • University Clinical Centre of Serbia
        • Contact:
          • Goran Stankovic
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital
      • Johns Creek, Georgia, United States, 30097
        • Emory Johns Creek Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
        • Contact:
          • Kevin Croce
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
        • Contact:
          • Imran Aslam
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Allina Health Minneapolis Heart Institute
        • Contact:
          • Manos Brilakis
    • New York
      • New York, New York, United States, 10467
        • Montefiore Medical Center
        • Contact:
          • Azeem Latib
        • Sub-Investigator:
          • Louis Verreault-Julien
        • Sub-Investigator:
          • Pier Pasquale Leone
      • New York, New York, United States, 10029
        • The Mount Sinai Hospital
        • Contact:
          • Shamin Sharma
      • New York, New York, United States, 10065
        • New York-Presbyterian/Weill Cornell Medical Center
        • Contact:
          • Jai Khatri
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital & Heart Center
        • Contact:
          • Ziad Ali
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Sanger Heart & Vascular Institute
        • Contact:
          • Nyal Borges
      • Durham, North Carolina, United States, 27707
        • Duke University Hospital
        • Contact:
          • Mariem Sawan
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
        • Contact:
          • Bernardo Cortese
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
        • Contact:
          • Leah Raj

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The participants are patients undergoing standard-of-care DCB PCI for de novo CAD at participating sites.

Eligibility will be determined by trained research personnel via a review of the EMR to ensure patients meet the inclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adults undergoing PCI with drug-coated balloons (DCB) for de novo coronary artery disease
All adult patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) for de novo coronary artery disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Target Lesion Failure (TLF)
Time Frame: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
Incidence of Target Lesion Failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR) will be documented.
At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
Mortality and Myocardial Infarction
Time Frame: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
Rates of all-cause mortality, cardiovascular death, and myocardial infarction (target vessel and non-target vessel) will be recorded.
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
Time Frame: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
Frequency of any repeat revascularization, specifically focusing on clinically driven TLR and clinically driven target vessel revascularization (TVR) will be assessed.
At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
Incidence of Target Vessel Failure (TVF) and definite/probable vessel thrombosis
Time Frame: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
The incidence of Target Vessel Failure (TVF) and definite/probable vessel thrombosis according to Academic Research Consortium (ARC) definitions will be documented.
At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
Number of bleeding events
Time Frame: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
The safety profile of post-procedural pharmacotherapy will be evaluated through the collection of bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria.
At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Pratik Sandesara, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2031

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026P000463

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual de-identified participant data will be shared between sites. All clinical data will be shared including demographics, clinical characteristics, procedural characteristics, and outcomes

IPD Sharing Time Frame

The data will be available to our site continuously and upon request for other sites.

IPD Sharing Access Criteria

The data will be available upon request for other sites and will be shared with participating sites sub-investigators for analyses.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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