Analysis of Revascularization in Ischemic Stroke With EmboTrap "ARISEII"

Recruiting

Phase N/A Results N/A

Trial Description

The study objective is to examine the recanalization efficacy of the EmboTrap device and its associated performance characteristics and to record associated clinical outcomes in a manner that facilitates relevant comparison of outputs with that of devices approved in the U.S. for clearing Large Vessel Occlusions.

Conditions

Interventions

  • EmboTrap® Revascularization Device Device
    Other Names: EmboTrap
    ARM 1: Kind: Experimental
    Label: EmboTrap® Revascularization Device
    Description: Mechanical Thromobectomy with EmboTrap

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary efficacy endpoint of the study is revascularization measured using modified Thrombolysis in Cerebrovascular Infarction (mTICI inclusive of the 2c rating). Day 0 No
Primary The primary safety endpoint will be measured as the occurrence of Symptomatic Intracerebral hemorrhage (sICH) within 24 hours (-8/+12 hrs) post-procedure, together with any other Serious Adverse Device Effects (excluding those already counted in sICH). 24 hours Yes
Secondary Good clinical outcome 90(±14) days Post Procedure No
Secondary Time to treat Day 0 No
Secondary All procedure-related mortality Day 7 No
Secondary All-cause Mortality 90(±14) days Post Procedure No
Secondary Serious Adverse Device Effect (SADE) 90(±14) days Post Procedure No
Secondary Procedure Related Serious Adverse Events (PRSAE) 90(±14) days Post Procedure No
Secondary Symptomatic ICH (sICH) 24 hours Post Procedure No
Secondary Neurological deterioration 24 hours Post Procedure No
Secondary Evidence of Infarction 24 hours post procedure No

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