OPTIXIENCE is an observational, international, multicentre and prospective study that aims to evaluate the clinical outcome of high-risk patients undergoing percutaneous coronary intervention (PCI) with everolimus-eluting stent implantation using intracoronary tools for PCI guidance and optimization. Within this trial, in total 1064 patients are planned to be enrolled. During the trial, clinical data will be collected and evaluated and compared with a historical control group.
Sponsor
Study objectives
The primary objective of the study is to assess the 1-year clinical outcome, in terms of target lesion failure (TLF), in high-risk patients undergoing PCI with stent implantation guided by intracoronary tools (imaging and/or pressure measurements) compared with patients in whom angiographic alone guided coronary stenting is performed.
Primary endpoints
The primary endpoint is the 1-year TLF rate, defined as a composite rate of cardiac death, target-vessel MI, and ischemia-driven TLR by either PCI or CABG, within 1 year after PCI.
CERC Services
- Hospital Contracts Management
- Monitoring activities
Countries
France, Spain, Portugal
Number of investigational sites
40
