Study Name Sort descending | Study Type | Patients | Status | Primary Endpoint | ||||
---|---|---|---|---|---|---|---|---|
BIO-RESORT | RCT | 3,514 | 36-month FU available | TVF at 12 months | ||||
BIODEGRADE | RCT | 3,850 | Primary endpoint reached | TLF at 18 months | ||||
BIOFLOW-I | FIM | 30 | Completed, 12-month FU available | LLL at 9 months | ||||
BIOFLOW-II | RCT | 452 | Completed, 60-month FU available | LLL at 9 months | ||||
BIOFLOW-III | Single arm registry | 1,356 | Completed, 60-month FU available | TLF at 12 months | ||||
BIOFLOW-INDIA | Single arm registry | 120 | Completed | LLL at 9 months | ||||
BIOFLOW-IV | RCT | 575 | Completed, 60-month FU available | TVF at 12 months | ||||
BIOFlow-SV | Single arm registry | 1,000 | TBA | TLF at 12 months | ||||
BIOFLOW-V | RCT | 1,334 | 36-month FU available | TLF at 12 months | ||||
BIOFLOW-VI | RCT | 440 | 12-Month FU available | LLL at 9 months | ||||
BIOFLOW-VII | Single arm registry | 556 | Enrollment completed | TLF at 12 months | ||||
BIOLUX-RCT | RCT | 210 | 12-month FU available | LLL at 6 months | ||||
BIONYX | RCT | 2,488 | 24-month FU available | TVF at 12 months | ||||
BIOSCIENCE | RCT | 2,119 | Completed, 60-month FU available | TLF at 12 months | ||||
BIOSTEMI* | RCT | 1,300 | Primary endpoint reached | TLF at 12 months | ||||
ESODE | RCT | 600 | Enrolling | MACE at 12 months | ||||
HATTRICK-OCT | RCT | 44 | Primary endpoint reached | Strut coverage at 3 months | ||||
ISAR OCT | RCT | 39 | Primary endpoint reached | Strut coverage at 6 months | ||||
ORIENT | RCT | 372 | Primary endpoint reached | LLL at 9 months | ||||
SCAAR | All comers registry | 69,570 | - | 24 months available | ||||
SMART-CHOICE | RCT | 3,000 | Primary endpoint reached | MACCE at 12 months | ||||
SORTOUT-IX | All comers RCT | 3,151 | Primary endpoint reached | TLF at 12 months | ||||
SORTOUT-VII | RCT | 2,525 | 36-month FU available | TLF at 12 months |
*Orsiro DES is not currently indicated for STEMI patients in the US.
Orsiro is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of ≤ 36 mm.