To determine the revascularization rate of the CE-marked Trevo device in large vessel occlusions in ischemic stroke patients.
- Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure.
- Clinical outcomes at 90 days
- Mortality at 90 days
- Device-related serious adverse events (DRSAEs)
- Symptomatic ICH rate within 24 (-6/+12) hours post-procedure
- Mechanical Thrombectomy (Merci Retriever)Device
Other Names: Penumbra system; TREVO; Solitaire Intervention Desc: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. ARM 1: Kind: Experimental Label: Acute Ischemic Stroke patients Description: Patients presenting with signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, who are candidates for mechanical embolectomy. ARM 2: Kind: Experimental Label: Acute Ischemic Stroke Description: Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke
- Allocation: Non-Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Single Group Assignment
Patients presenting with signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, who are candidates for mechanical embolectomy, will be enrolled in trial. Patients will be evaluated for symptoms of ICH during first 24 hours. Patients will be evaluated for primary and secondary outcomes at 90 days post procedure.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Revascularization status. Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure|
|Secondary||Clinical outcomes at 90 days; Mortality at 90 days; Device-related serious adverse events (DRSAEs); Symptomatic ICH rate within 24.|
|Secondary||Clinical outcomes at 90 days||90-day||No|
|Secondary||Mortality at 90 days||90-day||No|
|Secondary||Device-related serious adverse events (DRSAEs)||Procedure||Yes|
|Secondary||Symptomatic ICH rate within 24 (-6/+12 hours) post-procedure||Post procedure through 24 hours (-6/+12)||Yes|