Clinical Study Overviewa
| Study Name | Study Type | Patients | Status | Primary Endpoint Sort descending | ||||
|---|---|---|---|---|---|---|---|---|
| BIOFLOW-VI | RCT | 440 | 48-month FU available | LLL at 9 months | ||||
| BIOFLOW-II | RCT | 452 | Completed, 60-month FU available | LLL at 9 months | ||||
| BIOFLOW-I | FIM | 30 | Completed, 12-month FU available | LLL at 9 months | ||||
| BIOFLOW-INDIA | Single arm registry | 120 | Completed | LLL at 9 months | ||||
| ORIENT | RCT | 372 | Primary endpoint reached | LLL at 9 months | ||||
| SMART-CHOICE | RCT | 2,993 | Completed, Primary endpoint reached | MACCE at 12 months | ||||
| HATTRICK-OCT | RCT | 44 | Primary endpoint reached | Strut coverage at 3 months | ||||
| ISAR OCT | RCT | 75 | Completed, Primary endpoint reached |
Strut coverage at 6 and 24 months |
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| BIOSTEMIb | RCT | 1,300 | Completed, 24-month FU available | TLF at 12 months | ||||
| SORTOUT-IX | RCT | 3,151 | Completed, 36-month FU available | TLF at 12 months | ||||
| BIOFlow-SV | Single arm registry | 1,000 | TBA | TLF at 12 months | ||||
| BIOSCIENCE | RCT | 2,119 | Completed, 60-month FU available | TLF at 12 months | ||||
| BIOFLOW-VII | Single arm registry | 556 | Enrollment completed | TLF at 12 months | ||||
| BIOFLOW-V | RCT | 1,334 | Completed, 60-month FU available | TLF at 12 months | ||||
| SORTOUT-VII | RCT | 2,525 | Completed, 36-month FU available | TLF at 12 months | ||||
| Taglieri et al. | Network Meta-Analysis | 99,039 | Completed | TLF at 12 months and the longest FU available | ||||
| BIODEGRADE | RCT | 3,850 | Primary endpoint reached | TLF at 18 months | ||||
| Madhavan et al. | Meta-Analysis | 20,701 | Completed | TLF at latest FU reported | ||||
| SCAAR | All comers registry | 69,570 | 24-month FU available | TLR and ST at 12 months | ||||
| BIOFLOW-IV | RCT | 575 | Completed, 60-month FU available | TVF at 12 months | ||||
| BIONYX | RCT | 2,488 | 36-month FU available | TVF at 12 months | ||||
| BIO-RESORT | RCT | 3,514 | Completed, 36-month FU available | TVF at 12 months |
a A selection of the full clinical program of the Orsiro family.
b 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.