Safety and Efficacy of the Penumbra™ System in Acute Middle Cerebral Artery (MCA) Stroke

Hospital de Clinicas de Porto Alegre

Status and phase: Withdrawn; Phase 2

Conditions: Stroke

Treatments: Device: Penumbra™ System; Drug: Recombinant tissue plasminogen activator

Study type: Interventional

Funder types: Other

Identifiers

NCT01133223

GPPG 09-587

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Thrombectomy

Active Comparator group

Treatment:

Device: Penumbra™ System

Usual Care

Active Comparator group

Treatment:

Drug: Recombinant tissue plasminogen activator