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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

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ClinicalTrials.gov Identifier: NCT01584609
Recruitment Status : Active, not recruiting
First Posted : April 25, 2012
Last Update Posted : December 26, 2016
Information provided by (Responsible Party):
Penumbra Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke From Large Vessel Occlusion Device: Penumbra System with Separator 3D Device: Penumbra System alone Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Penumbra System with Separator 3D Device: 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 Device: 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.

Primary Outcome Measures :
  1. Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TICI score of 2 or 3 [ Time Frame: At immediate post-procedure ]
  2. Incidence of device-related and procedure-related serious adverse event [ Time Frame: Within 24 hours post-procedure ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 30 days post-procedure ]
  2. The proportion of patients with a modified Rankin Scale (mRS) score of ≤ 2 at 90 days post procedure [ Time Frame: at 90 days post-procedure ]
  3. All cause mortality [ Time Frame: At 90 days post-procedure ]
  4. Incidence of symptomatic intracranial hemorrhage [ Time Frame: At 90 days post-procedure ]
  5. Good neurological outcome at 90 days post-procedure as defined by an mRS score of ≤ 2, or equal to the pre-stroke mRS score if the pre-stroke mRS score was higher than 2, or an 10 or more points improvement on the NIHSS score [ Time Frame: At 90 days post-procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584609

United States, California
Hoag Hospital
Newport Beach, California, United States, 92658
United States, Colorado
Swedish Medical Center
Denver, Colorado, United States, 80112
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 6106
United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
United States, Minnesota
St. Joseph Hospital- Healtheast
St. Paul, Minnesota, United States, 55102
United States, New York
Kaleida Health
Buffalo, New York, United States, 14209
Stony Brook University Hospital
Stony Brook, New York, United States, 11794-8122
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Penumbra Inc.
Principal Investigator: Don Frei, MD Swedish Medical Center, Denver, CO

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT01584609     History of Changes
Other Study ID Numbers: CLP 4853
CLP 4853 ( Other Identifier: Penumbrainc )
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: December 26, 2016
Last Verified: December 2016

Keywords provided by Penumbra Inc.:
ischemic stroke
large vessel occlusion
mechanical thrombectomy
Penumbra System
Separator 3D

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Glucuronyl glucosamine glycan sulfate
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs