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

ELX-CL-1805

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.

Design

International, multicenter, randomized, single-blind study (First In Man in Japan, post-market in Germany). 444 Patients will be enrolled at sites in Japan (222) and Germany (222).

Primary endpoint

Target lesion failure (TLF) assessed at 12 months.

CERC Services

Data Management/EDC

Core Lab activities

Safety Management

Project Management

CEC activities

Countries

2 Countries

 Number of patients

444

Centers number

Up to 25 centers