Clinical study overview*
| Study Name | Clinical Flyer | Study Type | Patients | Status | Primary Endpoint | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BIOFLOW-V | RCT | 1334 | Completed, 60-months FU available | TLF at 12 months | ||||||||
| BIOSTEMI | RCT | 1300 | Completed, 60-months FU available | TLF at 12 months | ||||||||
| BIOFLOW-VIII | Registry | 872 | 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 | ||||||||
| HOST-IDEA | RCT | 2013 | 12-month FU available | TLF at 12 months | ||||||||
| Taglieri et al. | Network Meta-Analysis | 99039 | - | TLF at 12 months and the longest FU available | ||||||||
| Madhavan et al. | Meta-Analysis | 20701 | - | TLF at mean 30 months | ||||||||
| TPASS | RCT | 2850 | Completed, 12 months FU available | NACE at 12 months | ||||||||
| TICO | RCT | 3056 | Completed, primary endpoint reached | NACE at 12 months | ||||||||
| BIO-RESORT | RCT | 3514 | Completed, 60-month FU available | TVF at 12 months | ||||||||
| Hattrick-OCT | RCT | 44 | Primary endpoint reached | Strut coverage at 3 months | ||||||||
| BIONYX | RCT | 2488 | 36-month FU available | TVF at 12 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 | 1356 | Completed, 60-month FU available | TLF at 12 months | ||||||||
| BIOFLOW-IV | RCT | 575 | Completed, 60-month FU available | TVF at 12 months | ||||||||
| BIOFLOW-VI | RCT | 440 | Completed, 60-month FU available | LLL at 9 months | ||||||||
| SCAAR | All comers registry | 69570 | 24-month FU available | - | ||||||||
| HEROES | Single arm registry | 353 | 36-month FU available | DOCE at 12 months | ||||||||
| SORT OUT IX | RCT | 3151 | 24-month FU available | TLF at 12 months | ||||||||
| BIOSCIENCE | RCT | 2119 | Completed, 60-month FU available | TLF at 12 months | ||||||||
| BIOVASC | RCT | 764 | 24-month FU available | Composite primary endpoint | ||||||||
| PRISON-IV | RCT | 330 | Completed, 60-month FU available | LLL at 9 months | ||||||||
| BIOLUX-RCT | RCT | 210 | 18-month FU available | LLL at 6 months | ||||||||
| ORIENT | RCT | 372 | 36-month FU available | LLL at 9 months | ||||||||
| BIODEGRADE | RCT | 3850 | 36-month FU available | TLF at 18 months | ||||||||
| SMART-CHOICE | RCT | 3000 | Primary endpoint reached | MACCE at 15 months | ||||||||
| PREPARE-CALC | RCT | 200 | Completed | Strategy success and LLL at 9 months | ||||||||
| ISAR OCT | RCT | 39 | Primary endpoint reached | Strut coverage at 6 months | ||||||||
| SORT OUT X | RCT | 3146 | 12-month FU available | TLF at 12 months |
*a selection of the full clinical program of the Orsiro family.
Clinical data collected with either Orsiro DES or Orsiro Mission DES device within the Orsiro family clinical program.
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Specifications are subject to modification, revision and improvement.