ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany, Serbia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- 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]
- 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]
- 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]
- 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]
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 17 centers
- Banner University Medical Center — Phoenix
- Holy Cross Health Fort Lauderdale — Fort Lauderdale
- Emory University Hospital Midtown — Atlanta
- Emory University Hospital — Atlanta
- Emory Saint Joseph's Hospital — Atlanta
- Emory Johns Creek Hospital — Johns Creek
- Tufts Medical Center — Boston
- Brigham and Women's Hospital — Boston
- … and 9 more centers
Germany · 1 center
- Universitatsklinikum des Saarlandes — Homberg (Efze)
Serbia · 1 center
- University Clinical Centre of Serbia — Belgrade
Identifiers
NCT: NCT07559903 · 2026P000463