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.
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.
Study Type
OBSERVATIONAL
Enrollment
5,000
Banner University Medical Center
Phoenix, Arizona, United States
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
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
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
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
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.
Time frame: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
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Holy Cross Health Fort Lauderdale
Fort Lauderdale, Florida, United States
NOT_YET_RECRUITINGEmory University Hospital Midtown
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RECRUITINGTufts Medical Center
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NOT_YET_RECRUITINGBrigham and Women's Hospital
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