Coronary Artery Disease
Conditions
Keywords
Drug coated balloon, Percutaneous coronary intervention, Target lesion failure
Brief summary
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.
Interventions
None listed
Sponsors
Emory University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Infarction | At 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 Revascularization | At 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 thrombosis | At 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 events | At 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. |
Countries
Germany, Serbia, United States
Contacts
CONTACTDaniel Gold, MD
PRINCIPAL_INVESTIGATORPratik Sandesara, MD
Emory University
Outcome results
None listed