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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults undergoing PCI with drug-coated balloons (DCB) for de novo coronary artery disease | All adult patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) for de novo coronary artery disease. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Gold, MD | Contact | 314-761-3396 | daniel.alexander.gold@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pratik Sandesara, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Not yet recruiting | Phoenix | Arizona | 85006 | United States | |
Individual de-identified participant data will be shared between sites. All clinical data will be shared including demographics, clinical characteristics, procedural characteristics, and outcomes
The data will be available to our site continuously and upon request for other sites.
The data will be available upon request for other sites and will be shared with participating sites sub-investigators for analyses.
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| Holy Cross Health Fort Lauderdale |
| Not yet recruiting |
| Fort Lauderdale |
| Florida |
| 33308 |
| United States |
|
| Emory University Hospital Midtown | Recruiting | Atlanta | Georgia | 30308 | United States |
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
| Emory Saint Joseph's Hospital | Recruiting | Atlanta | Georgia | 30342 | United States |
| Emory Johns Creek Hospital | Recruiting | Johns Creek | Georgia | 30097 | United States |
| Tufts Medical Center | Not yet recruiting | Boston | Massachusetts | 02111 | United States |
|
| Brigham and Women's Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
|
| Allina Health Minneapolis Heart Institute | Not yet recruiting | Minneapolis | Minnesota | 55407 | United States |
|
| The Mount Sinai Hospital | Not yet recruiting | New York | New York | 10029 | United States |
|
| New York-Presbyterian/Weill Cornell Medical Center | Not yet recruiting | New York | New York | 10065 | United States |
|
| Montefiore Medical Center | Not yet recruiting | New York | New York | 10467 | United States |
|
| St. Francis Hospital & Heart Center | Not yet recruiting | Roslyn | New York | 11576 | United States |
|
| Sanger Heart & Vascular Institute | Not yet recruiting | Charlotte | North Carolina | 28203 | United States |
|
| Duke University Hospital | Not yet recruiting | Durham | North Carolina | 27707 | United States |
|
| University Hospitals Cleveland Medical Center | Not yet recruiting | Cleveland | Ohio | 44106 | United States |
|
| Vanderbilt University Medical Center | Not yet recruiting | Nashville | Tennessee | 37232 | United States |
|
| Universitatsklinikum des Saarlandes | Not yet recruiting | Homberg (Efze) | Germany |
|
| University Clinical Centre of Serbia | Not yet recruiting | Belgrade | Serbia |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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