The purpose of this observational clinical evaluation is to evaluate the safety and efficacy of the Solitaire FR Device in subjects requiring mechanical thrombectomy when used according to its Instruction For Use (IFU), in real life practice.
- Observation: Cohort
- Perspective: Prospective
- Sampling: Probability Sample
Patients presenting acute ischemic stroke with mechanical thrombectomy treatment deemed appropriate. Consecutive evaluation.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Arterial recanalization of the occluded target vessel measured by Thrombolysis in Cerebral Infarction (TICI) score equal or superior to 2b following the use of the Study Device.||Immediately post procedure (day 1)||No|
|Secondary||Rate of device-related and procedure related Serious Adverse Events (SAEs) as a measure of safety.||At hospital discharge or at 10 days post procedure if patient not discharged.||Yes|
|Secondary||Time to revascularisation||Post procedure||No|