MAGICAL SV is a prospective, multi-center, multinational, randomized, single-blind, pivotal, 2-arm parallel groups study. The objective is to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm) in patients with coronary artery disease.
A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of ~50% of enrollees.
Sponsor
Primary endpoints
- Target lesion failure (TLF), defined as the composite of cardiovascular mortality, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization, within 12months.
CERC Services
- Clinical report
- Clinical trial documentation
- Monitoring activities
- Project management
- Regulatory submissions
- Safety reporting
- Sites' contract management
Countries
Around 50 countries across Europe, North and South America.
Europe: France, Italy, Spain, Serbia, Poland, Switzerland, The Netherlands and the United Kingdom.
North America
Number of investigational sites
Unknown yet (+50)
