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 patient:

474

 

Center number:

Up to 40 centers