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

Withdrawn

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Penumbra™ System Device
    Intervention Desc: 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)
    ARM 1: Kind: Experimental
    Label: Thrombectomy
  • Recombinant tissue plasminogen activator Drug
    Intervention Desc: 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)
    ARM 1: Kind: Experimental
    Label: Usual Care

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional independence (modified Rankin Scale 0-2) 3 months No
Secondary Minimal or no disability (modified Rankin Scale 0-1) 3 months No
Secondary Overall mortality 7 days and 3 months Yes
Secondary Symptomatic cerebral bleeding rate 48 hours, 7 days and 3 months Yes

Sponsors