ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization "ARISE"

Suspended

Phase N/A Results N/A

Trial Description

A prospective pilot study to evaluate the recanalization and safety of mechanical thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal between 8 - 24 hours.

Detailed Description

Ischemic stroke patients who are 8-24 hrs from symptom onset without prior mechanical or IV thrombolytic treatment and are screen with CT or MR perfusion imaging showing penumbra and infarction not > 1/3rd the territory.

Trial Stopped: Similar large international competing trial with results of strong positive statistically benefit

Conditions

Interventions

  • Mechanical Thrombectomy (Merci Retriever)Device
    Other Names: Penumbra system; TREVO; Solitaire
    Intervention Desc: Mechanical thrombectomy by either Penumbra system, TREVO, or Solitaire retrieval device
    ARM 1: Kind: Experimental
    Label: Interventional mechanical thrombectomy
    Description: Mechanical thrombectomy with either Penumbra system, TREVO, or Solitaire device for acute stroke symptom onset between 8 - 24 hours
  • Penumbra system, TREVO, or Solitaire Device
    Intervention Desc: Mechanical thrombectomy by either Penumbra system, TREVO, or Solitaire retrieval device
    ARM 1: Kind: Experimental
    Label: Mechanical thrombectomy
    Description: Mechanical thrombectomy with either Penumbra system, TREVO, or Solitaire device

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Thrombolysis in Cerebral Infarction (TICI) score 6 months Yes
Secondary National Institutes of Health Stroke Scale (NIHSS) score 6 months Yes
Secondary Montreal Cognitive Assessment (MoCA) tool 6 months Yes
Secondary Modified Rankin Scale 6 months Yes

Sponsors