An international, multicentre, single-arm and prospective study with a historical control group (XIENCE V USA study) 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.
The hypothesis is that the clinical outcome of patients undergoing PCI with stent implantation can be improved with the use of intracoronary imaging (OCT or IVUS) and/or intracoronary pressure measurements (pressure guidewire) that allow PCI optimization compared with PCI guided by angiography alone.
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.
For comparison purposes, the definition of the primary endpoint is identical to that used in the XIENCE V USA study (ARC-1 definition).
Study management in France
- Kick off activities,
- Clinical trial documentation review,
- Regulatory submissions,
- Contract management,
- Project management,
- Safety reporting,
France managed by CERC.
Spain and Portugal managed by others CRO.
17 sites in France managed by CERC.