Penumbra

Overview

Status: Recruiting
Keywords: Ischemic Stroke , Recannulization , Separator 3D
IRB Number: 00057074
Specialty: Radiology/Interventional
Sub Specialties: Neurointerventional Radiology

Brief Summary

The purpose of this study is to assess the safety and effectiveness of the Separator 3D as a component of the Penumbra System in the revascularization of large vessel occlusion (>2.5mm in diameter) in acute ischemic stroke.

This is a prospective, randomized, single blind, concurrent controlled, multi-center study to assess up to 230 evaluable patients at up to 50 centers presenting with acute ischemic stroke from large vessels occlusions (>2.5mm in diameter) accessible to the Penumbra Separator 3D System for revascularization within 8 hours of symptom onset. They must be refractory to or not eligible for thrombolytic therapy and 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 the procedure. Each center will have two roll-in patients before actual enrollment. These patients will not be part of the trial but will be followed for 90 days post-procedure for safety.

 

Principal Investigator: Perry Ng
Department: Radiology Clinical
Co Investigator: Michael Wilder

Contact Information

Name:Perry Ng
Phone: 801-581-7553
Email: Perry.Ng@hsc.utah.edu

Inclusion Criteria

Inclusion Criteria

  • From 18 to 85 years of age
  • Present with symptoms consistent with an acute ischemic stroke for revascularization within 8 hours from symptom onset
  • Refractory to or not eligible for IV rtPA therapy, e.g., presenting between 0 and 3 hours from symptom onset AND contraindicated for IV rtPA, or presenting between 3 and 8 hours of symptom onset, or evidence of persistent occlusion from vascular imaging after IV rtPA. 
  • Evidence of a large vessel (>2.5mm in diameter) occlusion in the cerebral circulation
  • NIH Stroke Scale (NIHSS) score >8
  • Signed informed consent

Exclusion Criteria

Exclusion Criteria

  • History of stroke in the past 3 months
  • Females who are pregnant
  • Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score >1
  • Known severe allergy to contrast media
  • Uncontrolled hypertension (defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg)
  • CT evidence of the following conditions at randomization:
  1. ​Significant mass effect with midline shift
  2. Large infarct region >1/3 of the middle cerebral artery territory
  3. Evidence of intracranial hemorrhage
  • Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal
  • Angiographic evidence of preexisting arterial injury
  • Rapidly improving neurological status prior to enrollment
  • Bilateral stroke
  • Intracranial tumors
  • Known history of cerebral aneurysm or arteriovenous malformation
  • Known hemorrhagic diathesis, coagulation deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >1.7
  • Baseline platelets <50,000
  • Use of IV heparin in the past 48 hours with PPT >1.5 times the normalized ratio
  • Baseline glucose <50mg/dL or >300mg/dL
  • Life expectancy less than 90 days prior to stroke onset
  • Participation in another clinical investigation that could confound the evaluation of the study device