BIOADAPTOR RCT

Coronary Artery Disease (CAD)

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

ID: NCT04192747

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 in Japan, post-market in Germany). 444 Patients will be enrolled at sites in Japan (222) and Germany (222).

 Sponsor

ELIXIR MEDICAL CORPORATION

 Primary endpoints

Target lesion failure (TLF) assessed at 12 months.

 CERC Services

  • Project management
  • EDC and data management
  • CoreLab activities
  • Safety management
  • Clinical Events Committee (CEC) activities

 Countries

Belgium, Germany, Japan, New Zealand 

 Number of investigational sites

36

 Number of patients

444