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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 1 trial group
Group A: Adults undergoing PCI with drug-coated balloons (DCB) for de novo coronary artery disease

Trial outcomes

Primary outcomes

1

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.

Time frame
At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
2

Mortality and Myocardial Infarction

Rates of all-cause mortality, cardiovascular death, and myocardial infarction (target vessel and non-target vessel) will be recorded.

Time frame
At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
3

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.

Time frame
At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
4

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.

Time frame
At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge

Secondary outcomes

Other outcomes

Sponsors and contacts

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