Evaluation of a Sirolimus Eluting Bioadaptor as Compared to a Zotarolimus Eluting Stent in De novo Native Coronary Arteries
The objective of this study is to verify the safety and efficacy of the investigational device (ELX1805J) for the treatment of ischemic heart disease due to de novo, native coronary artery lesions.
International, multicenter, randomized, single-blind study (First In Man; referred to as Bioadaptor Study). 474 Patients will be enrolled at sites in Japan, New Zealand, Brazil, Taiwan, Singapore and Europe.
Target lesion failure (TLF) assessed at 12 months.
Core Lab activities
Regulatory submission (France, Taiwan, Singapore)
Monitoring (France, Taiwan, Singapore)
Number of patients
Up to 40 centers