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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Mortality and Myocardial Infarction
Rates of all-cause mortality, cardiovascular death, and myocardial infarction (target vessel and non-target vessel) will be recorded.
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.
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.
Sponsors and contacts
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