A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke

Recruiting

Phase 2/3 Results N/A

Trial Description

This is a prospective, randomized, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (>3mm in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra System with the Separator 3D or the Penumbra System without the Separator 3D. Each treated patient will be followed and assessed for 3 months after randomization. Up to 164 evaluable patients at up to 50 centers presenting with acute ischemic stroke in vessels accessible to the Penumbra Separator 3D System for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Penumbra System with the Separator 3D for the revascularization of large vessel occlusion is not inferior to the Penumbra System alone.

Conditions

Interventions

  • Penumbra System with Separator 3D Device
    Intervention Desc: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
    ARM 1: Kind: Experimental
    Label: Penumbra System with Separator 3D
  • Penumbra System alone Device
    Intervention Desc: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
    ARM 1: Kind: Experimental
    Label: Penumbra System alone

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TIMI/TICI score of 2 or 3 At immediate post-procedure No
Primary Incidence of device-related and procedure-related serious adverse event During the procedure Yes
Secondary Good clinical outcome at 30 days post-procedure as defined by a 10 points or more improvement in the NIHSS at Discharge, a NIHSS score of 0-1at Discharge; or a 30-day mRS score of 0-2 30 days post-procedure No
Secondary The proportion of patients with a modified Rankin Scale (mRS) of ≤ 2 at 90 days post treatment at 90 days post-procedure No
Secondary All cause mortality At 90 days post-procedure Yes
Secondary Incidence of symptomatic hemorrhage At 90 days post-procedure Yes

Sponsors