Table 1 Study outcome measures
Outcome measure type | Outcome measure description | Outcome measure definition |
|---|---|---|
Primary outcome measure | Target lesion primary patency at 1, 3, 6, and 12 months | The time between device placement and any subsequent intervention within the region where the device was implanted or access circuit thrombosis |
Primary safety outcome measure | 30-day safety | Freedom from localized or systemic serious adverse events through 30 days post-procedure |
Secondary outcome measure | Technical success | Successful deployment of the device at the intended location |
Secondary outcome measure | Procedural success | Achieving < 30% residual stenosis following the completion of the procedure accompanied by the resolution of the preprocedural clinical indicators of access dysfunction |
Secondary outcome measure | Access circuit primary patency at 1, 3, 6, and 12 months | The time spanning from device placement to the initial intervention anywhere within the access circuit or in the event of access circuit thrombosis |
Secondary outcome measure | Target lesion secondary patency at 1, 3, 6, and 12 months | The time from initial device placement until the AVG or AVF was abandoned |