Safety and Efficacy of the Penumbra™ System in Acute Middle Cerebral Artery (MCA) Stroke
Phase 2
Withdrawn
- Conditions
- Stroke
- Interventions
- Device: Penumbra™ System
- Registration Number
- NCT01133223
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Thrombectomy Penumbra™ System - Usual Care Recombinant tissue plasminogen activator -
- Primary Outcome Measures
Name Time Method Functional independence (modified Rankin Scale 0-2) 3 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil