Basic HTML Version
Study
design
–
A prospective, multi-centre, single treatment
clinical trial
–
Endpoint: LLL 9 months, N=30
–
A prospective, multi-center, non-inferiority,
randomized study, Orsiro vs. Xience Prime
–
Endpoint: LLL at 9 months, N=440
–
A prospective, multi-centre, single treatment
clinical study
–
Endpoint: LLL at 9 months, N=120
–
A prospective, multi-centre, single treatment clinical
registry
–
Endpoint: TLF at 9 months, with long term follow-up,
N=1000+
–
Comparative, non-inferiority trial evaluating safety
and efficacy
–
Study to evaluate safety and efficacy in a complex
patient population
–
Post marketing surveillance to demonstrate long term
outcomes
–
First-in-man study evaluating safety and efficacy,
data submitted during CE approval (TÜV)
Clinical
strategy
Study
design
Clinical
strategy
BIOFLOW Clinical Program for
Orsiro Hybrid Drug Eluting Stent