The European Bifurcation Club randomized trial of stepwise provisional stenting versus Drug Coated Balloon Therapy for non-left main true coronary bifurcations
Legal Representative of Sponsor in European Union: CERC
Investigator Initiated Trial
The EBC DCB study is an investigator initiated, multi-centre, prospective, randomised (1:1) clinical trial with non-inferiority and subsequently superiority testing. The objective is to determine if DCB treatment of coronary bifurcation disease is non-inferior in clinical outcome to a provisional stenting strategy with DES deployment and Kissing Balloon Inflation at 1-year.
The study plans to enroll 750 patients with coronary bifurcation disease, patients will be followed up to 8-years.
Sponsor
Primary endpoints
Bifurcation Orientated Composite Endpoint (BOCE) at 1 year, consisting of the following components:
- Cardiovascular death
- Target bifurcation-related myocardial infarction
- Target bifurcation revascularisation.
CERC Services
- CEC activities
- Clinical report
- Clinical trial documentation
- CoreLab activities
- EDC and data management
- Monitoring activities
- Regulatory submissions
- Safety reporting
- Set-up activities (sites selection, insurance management, contract management)
- Statistical Activities
Countries
8 countries across Europe (7 countries) and Asia.
Europe: Finland, France, Germany, Italy, Serbia, Spain and the United Kingdom.
Asia: South-Korea.
Number of investigational sites
20.
