Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)

Completed

Phase N/A Results

Trial Description

The main objective of this study is to document that the thrombectomy catheter (Rev-01) is effective and safe when used for revascularization in subjects with acute ischemic stroke within 8 hours of symptom onset who are ineligible for treatment with IV t-PA, or in whom treatment with IV t-PA has been ineffective.

Conditions

Interventions

  • Rev-01 Device
    Intervention Desc: Treatment arm patients have used Rev-01 at least once
    ARM 1: Kind: Experimental
    Label: Treatment
    Description: Intervention Device: Rev-01

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of patients who have recanalization immediately post device procedural angiograms, after the device is removed and before final closure No
Secondary Following neurological outcomes - mRS score - NIHSS score - BI score 90-day No
Secondary Proportion of patients with ICH (symptomatic and asymptomatic) 24-hour post procedure Yes
Secondary All cause mortality 90 days post-procedure Yes
Secondary Proportion of Subject Who Have Clot Migration/Embolization immediately post procedure No
Secondary Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure 90 days post procedure No
Secondary Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH) 24-hour post procedure Yes

Sponsors