Stroke
Conditions
Keywords
Stroke, mecanical thrombectomy
Brief summary
Stroke prognosis is intimately related to reperfusion. Reperfusion in acute setting can be achieved with different strategies - varying from intravenous rtPA from mechanical thrombectomy. Recently, interventional approaches have been gaining attention and playing an increasing role in stroke care. However, no solid scientifical data is available to date. The investigators want do conduct a pilot trial to test if the use of the Penumbra™ System can improve clinical outcomes in a specific stroke setting.
Interventions
DEVICEPenumbra™ System
Patients assigned to the Thrombectomy arm will be conducted to the angio suite. Mechanical thrombectomy will be attempted with the use of the Penumbra™ System, and can be assisted by intraarterial thrombolysis (rTPA up to 20 mg)
Patients assigned to Usual Care arm will be thrombolysed according to the NINDS protocol (rtPA 0,9 mg/kg, 10% IV bolus and remaining in the next hour, up to 90 mg)
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient enrolled in acute ischemic stroke protocol * Up to 3,5h from symptoms onset * Clinical findings compatible with middle cerebral artery syndrome * Angiotomographic evidence of proximal middle cerebral artery occlusion
Exclusion criteria
* NIHSS \< 10 * Overt contraindication to thrombolysis or angiopgraphy * Disagreement with informed consent term or refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional independence (modified Rankin Scale 0-2) | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Minimal or no disability (modified Rankin Scale 0-1) | 3 months |
| Overall mortality | 7 days and 3 months |
| Symptomatic cerebral bleeding rate | 48 hours, 7 days and 3 months |
Countries
Brazil
Outcome results
None listed