NCT01133223
Withdrawn
Phase 2
Randomized Clinical Trial Comparing Intravenous Thrombolysis With Thrombectomy by the Penumbra™ System in Patients With Middle Cerebral Artery Stem Occlusion - Pilot Study
ConditionsStroke
Overview
- Phase
- Phase 2
- Intervention
- Penumbra™ System
- Conditions
- Stroke
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Locations
- 1
- Primary Endpoint
- Functional independence (modified Rankin Scale 0-2)
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
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.
Investigators
Lucas Scotta Cabral
Lucas Scotta Cabral
Hospital de Clinicas de Porto Alegre
Eligibility Criteria
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
Arms & Interventions
Thrombectomy
Intervention: Penumbra™ System
Usual Care
Intervention: Recombinant tissue plasminogen activator
Outcomes
Primary Outcomes
Functional independence (modified Rankin Scale 0-2)
Time Frame: 3 months
Secondary Outcomes
- 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)
Study Sites (1)
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