Evaluation of a Sirolimus Eluting Bioadaptor as Compared to a Zotarolimus Eluting Stent in De novo Native Coronary Arteries


Brief summary:

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.

Primary endpoint:

Target lesion failure (TLF) assessed at 12 months.


CERC Services:

Data Management/EDC

Core Lab activities

Regulatory submission (France, Taiwan, Singapore)

Monitoring (France, Taiwan, Singapore)

Safety Management

Project Management

CEC activities



10 Countries


 Number of patient:



Center number:

Up to 40 centers