Support C Post-Market Registry

Coronary Artery Disease (CAD)

Single-arm, Prospective, Open label, All Comers, Multicenter Registry. 
The objective is to collect and evaluate clinical data regarding the safety and performance of the Support C in a real-world setting (in clinical routine)

 Sponsor

OrbusNeich

 Primary endpoints

Adjudicated, device-oriented, Target Lesion Failure (TLF) at 12- months post procedure, where TLF is defined as a composite of cardiac death (CD), non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel (TV-MI), or clinically driven target lesion revascularization (cd-TLR) (by PCI or coronary artery bypass grafting).

 CERC Services

  • Clinical trial documentation
  • Project management
  • Monitoring activities
  • Safety reporting
  • Clinical report
  • Statistical Activities

 Countries

4 countries:
Europe: Spain, Czech Republic Germany.
Asia: Malaysia.

 Number of investigational sites

12