Single-arm, Prospective, Open label, All Comers, Multicenter Registry.
The objective is to assess safety and performance of EucaLimus, a sirolimus eluting PTCA stent system, in a prospective study as part of the manufacturer‘s post-market surveillance program
Sponsor
Primary endpoints
- Adjudicated, device-oriented endpoint Target Lesion Failure (TLF) at 12- months. TLF is defined as a composite of cardiac death (CD), non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel (TVMI) or clinically driven target lesion revascularization (cd-TLR)
CERC Services
- Clinical report
- Regulatory submissions
- Project management
- Monitoring activities
- Safety reporting
- Statistical Analysis
Countries
3 countries:
Europe: Spain, Czech Republic.
Asia: Malaysia.
Number of investigational sites
10
