Tranform II is an investigator-drive prospective, multicentric, international, randomized clinical trial. The objective is to observe and evaluate the efficacy of Magic Touch SCB compared to the gold standard treatment for native vessel disease, namely new-generation everolimus-eluting DES. The objective is to enroll 1820 patients eligible for PCI at 58 investigational sites and patients will be followed up to 5 years after procedure.
Sponsor
Study objectives
The purpose of TRANSFORM II study is to observe and evaluate the efficacy of Magic Touch SCB compared to the gold standard treatment for native vessel disease, namely new-generation everolimus-eluting DES. Only patients with coronary vessels up to 3.5 mm of diameter (by visual estimation) will be enrolled in this study.
Primary endpoints
The primary objective of the study is to verify the non-inferiority of Magic Touch SCB compared to everolimus-eluting DES (EES) in terms of TLF, a composite clinical endpoint, at 12 months.
CERC Services
- Contract management
- Monitoring activities
- Project management
- Regulatory submissions
Countries
Bangladesh, Malaysia, Brunei,Thailand & Poland
Number of investigational sites
14
