ANDREAS Registry for Coronary Artery Disease with Drug-Coated Balloons
This study, called the ANDREAS Registry, is looking at how well drug-coated balloons (DCB) work for adults with coronary artery disease (CAD). CAD is a condition where the blood vessels that supply the heart become narrowed. Doctors use a procedure called PCI (percutaneous coronary intervention) to open these narrowed vessels, and in this study, they are specifically using DCBs. The study will follow patients for up to 5 years to see how often they experience problems like target lesion failure (when the treated area narrows again), heart attacks, or need repeat procedures. This is an observational study, meaning doctors will use DCBs as they normally would, and the study will collect information on the outcomes. You can join if you are an adult (18 or older) having a PCI for new CAD using a DCB.
- Study design
- This is an observational, international study collecting information from 5000 participants. It is a registry, meaning it collects data on treatments given as part of routine care.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed at hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)
At a glance
Conditions
Where it's being run
19 sites across 11 statesStudy leadership
- Pratik Sandesara, MD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Incidence of Target Lesion Failure (TLF)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.
- Mortality and Myocardial InfarctionAt 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.
- Number of any repeat RevascularizationAt 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.
- Incidence of Target Vessel Failure (TVF) and definite/probable vessel thrombosisAt 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.
- Number of bleeding eventsAt 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.