Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan RCT

Terminated

Phase N/A Results N/A

Trial Description

The aim of this study is to clarify the efficacy of the endovascular treatment for acute ischemic stroke patients with large vessel occlusion and are not respond to intravenous recombinant tissue plasminogen activator (rt-PA) therapy.

Trial Stopped: Evidence of thrombectomy for acute stroke was established

Conditions

Interventions

  • Rescue endovascular therapy Procedure
    Intervention Desc: endovascular treatment using any devises for acute ischemic stroke patients with large vessel occlusion and not respond to intravenous recombinant tissue plasminogen activator (rt-PA) therapy
    ARM 1: Kind: Experimental
    Label: Group with endovascular treatment
    Description: Group with additional endovascular treatment
  • No endovascular therapy Procedure
    ARM 1: Kind: Experimental
    Label: Group without endovascular treatment
    Description: Group without additional endovascular treatment

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Assessment of modified Rankin Scale shift analysis at 90 days after onset 90 days No
Secondary The rate of mRS 0-2 at 90 days (+/- 10 days) after onset 90 days No
Secondary Death within 90 days (+/- 10 days) after onset 90 days Yes
Secondary Revascularization rates of the target vessel at 72 hours (+/- 8 hours) after onset 72 hours No
Secondary Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset 72 hours Yes
Secondary The difference of NIHSS score between pre-treatment and at 72 hours (+/- 8 hours) after onset 72 hours No

Sponsors