Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study "PRIISM"

Completed

Phase 2 Results

Trial Description

The primary study objective is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients experiencing an ischemic stroke.

Detailed Description

The objective of PRIISM is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients with acute ischemic stroke. Safety will be assessed by the device-related serious event rate as it compares to other similar therapies. The events include but are not limited to symptomatic hemorrhage, vessel dissection, embolization and overall morbidity and mortality. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.

Conditions

Interventions

  • MindFrame™ IRIIS™ System Device
    Other Names: IRIIS System; Clot; Thrombus; Mechanical Thrombectomy; Ischemic Stroke; Intervention; Neurovascular
    Intervention Desc: Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke
  • MindFrame System Device
    Other Names: IRIIS System; Clot; Thrombus; Mechanical Thrombectomy; Ischemic Stroke; Intervention; Neurovascular
    Intervention Desc: Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke
    ARM 1: Kind: Experimental
    Label: Treatment Arm

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary acute outcome measure is successful vessel recanalization using the IRIIS Device in absence of serious adverse events related to the device. treatment through 90 days Yes
Primary Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter. Immediately postprocedure No
Primary Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram. Immediately postprocedure No
Primary Clinical Success 90 days postprocedure No
Secondary Number of Device-related Serious Adverse Events Treatment to 90 days postprocedure Yes

Sponsors