A Prospective Randomized (1:1), Multi-center, International, Open label Clinical trial. The objective is to demonstrate non-inferiority for Target Vessel Failure (TVF) of a treatment strategy with first line SELUTION SLR Drug Eluting Balloon (DEB) plus provisional Drug Eluting Stent (DES) vs. systematic treatment with DES for the treatment of de novo coronary lesions, at 1 year and 5 years.
Sponsor
Primary endpoints
- Target Vessel Failure (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-Target Vessel Revascularization)) at 1 year
- Target Vessel Failure at 5 years
CERC Services
- Regulatory submissions
- Project management
- Site and Monitoring Management
- Core Laboratory
- Safety management
- Statistical Activities
- CEC and DSMB activities
Countries
Up to 15 countries: Austria, Czech Republic, Finland, France, Germany, Italy, Poland, Singapore, Spain, Switzerland, The Netherlands, UK
Number of investigational sites
Up to 80 sites (41 activated sites, submissions ongoing)
Number of patients
3326 patients
