Clinical study overview*

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Study Name Study Type Patients Status Primary Endpoint
SCAAR All comers registry 69570 24-month FU available -
BIOFLOW-I FIM 30 Completed, 12-month FU available LLL at 9 months
Madhavan et al. Meta-Analysis 20701 - TLF at mean 30 months
Taglieri et al. Network Meta-Analysis 99039 - TLF at 12 months and the longest FU available
BIOLUX-RCT RCT 210 18-month FU available LLL at 6 months
BIOFLOW-V RCT 1334 Completed, 60-months FU available TLF at 12 months
BIONYX RCT 2488 36-month FU available TVF at 12 months
ORIENT RCT 372 36-month FU available LLL at 9 months
BIO-RESORT RCT 3514 Completed, 60-month FU available TVF at 12 months
SORT OUT X RCT 3146 12-month FU available TLF at 12 months
BIOFLOW-DAPT RCT 1948 12-month FU available Composite of Cardiac death, Myocardial Infarction and Definite or probable Stent thrombosis at 12 months
BIOFLOW-VI RCT 440 Completed, 60-month FU available LLL at 9 months
PRISON-IV RCT 330 Completed, 60-month FU available LLL at 9 months
BIOSTEMI RCT 1300 Completed, 60-months FU available TLF at 12 months
SORT OUT IX RCT 3151 24-month FU available TLF at 12 months
HOST-IDEA RCT 2013 12-month FU available TLF at 12 months
BIOFLOW-II RCT 452 Completed, 60-month FU available LLL at 9 months
PREPARE-CALC RCT 200 Completed Strategy success and LLL at 9 months
BIODEGRADE RCT 3850 36-month FU available TLF at 18 months
BIOFLOW-IV RCT 575 Completed, 60-month FU available TVF at 12 months
REVELATION RCT 120 Primary endpoint reached FFR at 9 months
Hattrick-OCT RCT 44 Primary endpoint reached Strut coverage at 3 months
SMART-CHOICE RCT 3000 Primary endpoint reached MACCE at 15 months
TICO RCT 3056 Completed, primary endpoint reached NACE at 12 months
ISAR OCT RCT 39 Primary endpoint reached Strut coverage at 6 months
BIOSCIENCE RCT 2119 Completed, 60-month FU available TLF at 12 months
HEROES Single arm registry 353 36-month FU available DOCE at 12 months
ROSES Single arm registry 460 Preliminary results available TLF at 12 months
BIOFLOW-III Single arm registry 1356 Completed, 60-month FU available TLF at 12 months

*a selection of the full clinical program of the Orsiro family.

Clinical data conducted with Orsiro, Orsiro Mission’s predecessor device can be used to illustrate Orsiro Mission clinical outcomes.

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