Bioflow V

BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions - V

Bioflow V [NCT02389946]

Description:  The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent system.

Device: Orsiro DES
Device: Xience DES

Primary Investigator: Kereiakes

Drug/Device Information
To assess the safety & efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of up to three native de novo or restenoticlesions compared to the Xience coronary stent system
The ORSIRO stent system is a drug eluting balloon expandable stent
Comprised of the PRO-Kinetic Energy (PKE) Stent and the the drug-polymer coating is a formulation of Sirolimus with a bioresorbable Poly-L-lactic acid (PLLA) polymer excipient
Randomized in a 2:1 ratio to receive either the Orsiro Sirolimus Eluting Stent or the Xience Everolimus Eluting Stent
Biotronik, Inc.