CYCLOPES is a prospective, multicenter, open-label, single arm trial assessing the feasibility and efficacy of an intracoronary ultrasound guided algorithm for calcium modification in patients undergoing percutaneous coronary intervention (PCI) for chronic calcific coronary artery disease. The study will enroll 500 patients who will undergo PCI with calcium modification and patients will be followed up to 12 months after procedure.
Primary endpoints
- Minimum stent area (MSA) at the site of maximum calcification measured at the end of the index procedure
- Target lesion failure (TLF) (cardiovascular death, non-fatal myocardial infarction (MI) related to the target vessel, unplanned ischemia-driven target lesion revascularization) at 1 year
CERC Services
- CEC activities
- Clinical trial documentation
- CoreLab activities (IVUS)
- Overall Project management
- Presentation and Publication (option)
- Project management
- Regulatory submissions
- Safety management
- Set-up activities (sites selection, insurance management, contract management)
Countries
7 countries across Europe: Ireland, Switzerland, the United Kingdom, Spain, France, Italy and Germany
Number of investigational sites
25
