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The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations - EBC DCB Study
Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Thus, the primary objective of this study is to determine if Drug Coated Balloon treatment of non-left main true coronary artery bifurcation lesions is non-inferior (similar) to a provisional strategy with Drug Eluted Stent deployment.
Details
| Lead sponsor | Ceric Sàrl |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 750 |
| Start date | 2025-05 |
| Completion | 2035-08 |
Conditions
- Coronary Artery Disease (non-left Main)
- Coronary Bifurcation Lesion
Interventions
- Percutaneous Coronary Angioplasty
- Stepwise Provisional Stent Strategy
- Drug Coated Balloon Strategy
- Cross-Over Stepwise Provisional Stent Strategy
Primary outcomes
- Bifurcation Orientated Composite Endpoint (BOCE) — At 1-year, after the day of enrollment
The BOCE is defined by: * cardiovascular death, * target bifurcation-related myocardial infarction or * target bifurcation revascularisation