bioadaptor

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; 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

 

Countries

10 Countries

 

 Number of patients

474

 

Centers number

Up to 40 centers