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

NCT07559903 | Not Yet Recruiting

• 1 other identifier: 2026P000463
• Study Type: observational
• Target: 5,000
• Locations: 3 countries
• Sites: 18

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Drug coated balloon; Percutaneous coronary intervention; Target lesion failure

Outcome Measures

Primary Outcomes (5)

• Incidence of Target Lesion Failure (TLF)

  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

  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

  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

  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

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All adult patients (≥ 18 years of age) undergoing PCI for de novo CAD using DCB

You may not qualify if:

• Patients under the age of 18; PCI procedures without the utilization of DCB; PCI procedures for non de novo lesions

Sponsors & Collaborators

• Emory University: lead

Study Sites (18)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Allina Health Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

New York-Presbyterian/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

St. Francis Hospital & Heart Center

Roslyn, New York, 11576, United States

Location

Sanger Heart & Vascular Institute

Charlotte, North Carolina, 28203, United States

Location

Duke University Hospital

Durham, North Carolina, 27707, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Universitatsklinikum des Saarlandes

Homberg (Efze), Germany

Location

University Clinical Centre of Serbia

Belgrade, Serbia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Pratik Sandesara, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Gold, MD

CONTACT

314-761-3396; daniel.alexander.gold@emory.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available to our site continuously and upon request for other sites.
• Access Criteria: The data will be available upon request for other sites and will be shared with participating sites sub-investigators for analyses.

Locations

US (16); DE (1); SE (1)