Analysis of Revascularisation in Ischemic Stroke With EmboTrap "ARISE"

Active, not recruiting

Phase N/A Results N/A

Trial Description

A.R.I.S.E. is a post approval observational study using standard care. The purpose of this study is to collect information about the ability of the EmboTrap device to remove blood clots from the brain, and the associated performance characteristics and clinical outcomes. No formal hypothesis testing is needed as no comparisons are planned within the study. Instead, estimates of each population parameter of interest for all primary and secondary endpoints will be provided using appropriate confidence intervals.

Conditions

Interventions

  • EmboTrap® Revascularization Device Device
    Other Names: EmboTrap
    ARM 1: Kind: Experimental
    Label: EmboTrap® Revascularization Device
    Description: The EmboTrap® Revascularization Device is the investigational device

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Ischemic stroke patients

Outcomes

Type Measure Time Frame Safety Issue
Primary Revascularisation as measured by modified Thrombolysis in Cerebrovascular Infarction (mTICI with 2c) score of at least 2b following the use of the Neuravi device. Day 1 No
Secondary Time to Revascularization Day 1 No
Secondary Mortality post procedure 7 and 90(±14) days post procedure No
Secondary Serious Adverse Device related effects (SADE) 24(-8/+12) hours Post Procedure No
Secondary Symptomatic ICH 24(-8/+12) hours Post Procedure No
Secondary Clinical outcome at 90 days 90(±14) days Post Procedure No
Secondary Rate of New Territory Embolization 24(-8/+12) hours Post Procedure No
Secondary Evidence of Infarction 24(-8/+12) hours Post Procedure No

Sponsors