Assess the Penumbra System in the Treatment of Acute Stroke "THERAPY"

Active, not recruiting

Phase 4 Results N/A

Trial Description

The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the brain. IV rtPA is the only drug approved for the treatment of acute ischemic stroke but it does not work very well in cases where the stroke is caused by a large vessel occlusion. The hypothesis being tested is to determine if the addition of a treatment by a mechanical thrombectomy device like the Penumbra System can improve the clinical outcome of the patient over just using IV rtPA alone.

Detailed Description

Current therapies for acute stroke are limited to the intravenous administration of a intravenous (IV) recombinant human tissue plasminogen activator (rtPA) for thrombolysis of the affected cerebral arteries within 3-4.5 hours from symptom onset, and the use of intra-arterial (IA) endovascular mechanical clot retrieval devices within 8 hours from ictus, all of which have limitations as mono therapies. For example, IV rtPA may not be very efficacious in large vessel occlusion and the long term effects of mechanical thrombectomy devices on patient functional outcome is unknown. This is a randomized, concurrent controlled study to assess the safety and effectiveness of the Penumbra System as adjunctive therapy to IV rtPA in the acute intervention of acute ischemic stroke. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large clot burden (clot length > 8mm) in the anterior circulation will be assigned to either IV rtPA therapy alone (0.9mg/kg to a maximum of 90mg) or a combined IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and intra-arterial (IA) adjunctive treatment with the Penumbra System. Each treated patient will be followed and assessed for 3 months after enrollment.

Conditions

Interventions

  • Intravenous (IV) recombinant human tissue plasminogen activator (rtPA) Drug
    Other Names: recombinant tissue plasminogen activator, Alteplase
    Intervention Desc: 0.9mg/kg to a maximum of 90mg
    ARM 1: Kind: Experimental
    Label: IV rtPA
    Description: IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg
  • Penumbra System Device
    Intervention Desc: The Penumbra System is an aspiration based mechanical thrombectomy device
    ARM 1: Kind: Experimental
    Label: IV rtPA and IA Penumbra System
    Description: Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Good functional outcome as defined by a modified Rankin score of 0-2 90 days No
Primary Incidence of all serious adverse events 90 days Yes
Secondary Good clinical outcome 30 days No
Secondary Incidence of symptomatic and asymptomatic intracranial hemorrhage 90 days Yes
Secondary Ordinal improvement in 90-day mRS 90 days No
Secondary 24-hr infarct volume 24 hours No

Sponsors