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

September 11, 2018 updated by: Penumbra Inc.
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (2.5mm or greater 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 230 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Newport Beach, California, United States, 92658
        • Hoag Hospital
    • Colorado
      • Denver, Colorado, United States, 80112
        • Swedish Medical Center
    • Connecticut
      • Hartford, Connecticut, United States, 6106
        • Hartford Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Health System
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • St. Joseph Hospital- Healtheast
    • New York
      • Buffalo, New York, United States, 14209
        • Kaleida Health
      • Stony Brook, New York, United States, 11794-8122
        • Stony Brook University Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 or greater in diameter) occlusion in the cerebral circulation
  • NIH Stroke Scale (NIHSS) score 8 or more points
  • Signed informed consent

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 or higher
  • 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:

    • Significant mass effect with midline shift
    • Large infarct region >1/3 of the middle cerebral artery territory
    • 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 PTT >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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Penumbra System with Separator 3D
The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
Active Comparator: Penumbra System alone
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Angiographic Revascularization of the Occluded Target Vessel
Time Frame: At immediate post-procedure
Number of Participants with Angiographic revascularization of the occluded target vessel defined by mTICI grade 2-3
At immediate post-procedure
Number of Device-related Serious Adverse Events
Time Frame: Within 24 hours post-procedure
Within 24 hours post-procedure
Number of Procedure-related Serious Adverse Event
Time Frame: Within 24 hours post-procedure
Within 24 hours post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Good Clinical Outcome at 30 Days
Time Frame: 30 days post-procedure
Defined by a 10 points or more improvement in the NIHSS at Discharge, a NIHSS score of 0-1 at Discharge; or a 30-day mRS score of 0-2. The NIHSS is a stroke scale that measures impairment caused by stroke. The Modified Rankin scale (mRS) measures neurological disability or dependence for stroke patients.
30 days post-procedure
Number of Participants With 90 Day mRS Score 0-2
Time Frame: at 90 days post-procedure
at 90 days post-procedure
All Cause Mortality
Time Frame: At 90 days post-procedure
At 90 days post-procedure
Number of Symptomatic Intracranial Hemorrhage
Time Frame: Within 24 hours post-procedure
Within 24 hours post-procedure
Good Neurological Outcome at 90 Days
Time Frame: At 90 days post-procedure
Defined by an mRS score of 0-2, or equal to the pre-stroke mRS score if the pre-stroke mRS score was higher than 2, or an improvement of 10 or more points on the NIHSS score
At 90 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Don Frei, MD, Swedish Medical Center, Denver, CO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (Estimate)

April 25, 2012

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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