The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™ Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.
- SOLITAIRE™ Device compared to MERCI® Device Device
Intervention Desc: SOLITAIRE™ Device (investigational device) compared with the commercially available device, MERCI® Device ARM 1: Kind: Experimental Label: SOLITAIRE™ Device Description: The SOLITAIRE™ Device (investigational device) is the experimental arm ARM 2: Kind: Experimental Label: MERCI® Device Description: The MERCI® Device (control device) is commercially available.
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI)score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage.||Immediately post treatment||No|
|Secondary||Time to initial recanalization Measurement of patient's neurological condition including NIH Stroke Scale, Barthel Index and Modified Rankin Score at 30 and 90 days post procedure Rate of morbidity and mortality Incidence of symptomatic hemorrhage||30 and 90 days post treatment||No|
- ev3 Lead