An Investigator-initiated, multi-center, randomized controlled trial to compare the outcome of the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent in a PCI population at high bleeding risk.
ID: NCT04500912
Sponsor
Pieter C.Smits, MD
Primary endpoints
Net Adverse Clinical Endpoints (NACE) defined as a composite of cardiovascular death, MI, TVR, stroke and major bleeding events (BARC 3 or 5) at 12 months.
- Kick-off activities
- Clinical trials documentation
- Project management
- Clinical Events Committee (CEC) activities
- Corelab activities
- Data monitoring Committee (DMC) activities
- Statistical activities
- Administrative tasks
CERC Services
- Clinical trial documentation
- Project management
- Clinical Events Committee (CEC) activities
- CoreLab activities
- Monitoring activities
- Statistical Activities
Countries
The Netherlands
Number of investigational sites
10
Number of patients
736
