- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01584609
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
Status
Completed
Intervention / Treatment
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
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California
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Newport Beach, California, United States, 92658
- Hoag Hospital
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Colorado
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Denver, Colorado, United States, 80112
- Swedish Medical Center
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Connecticut
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Hartford, Connecticut, United States, 6106
- Hartford Hospital
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Georgia
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Atlanta, Georgia, United States, 30303
- Grady Health System
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Minnesota
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Saint Paul, Minnesota, United States, 55102
- St. Joseph Hospital- Healtheast
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New York
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Buffalo, New York, United States, 14209
- Kaleida Health
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Stony Brook, New York, United States, 11794-8122
- Stony Brook University Hospital
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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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 |
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Experimental: Penumbra System with Separator 3D
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The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
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Active Comparator: Penumbra System alone
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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.
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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
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Number of Participants with Angiographic revascularization of the occluded target vessel defined by mTICI grade 2-3
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At immediate post-procedure
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Number of Device-related Serious Adverse Events
Time Frame: Within 24 hours post-procedure
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Within 24 hours post-procedure
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Number of Procedure-related Serious Adverse Event
Time Frame: Within 24 hours post-procedure
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Within 24 hours post-procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Good Clinical Outcome at 30 Days
Time Frame: 30 days post-procedure
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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.
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30 days post-procedure
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Number of Participants With 90 Day mRS Score 0-2
Time Frame: at 90 days post-procedure
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at 90 days post-procedure
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All Cause Mortality
Time Frame: At 90 days post-procedure
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At 90 days post-procedure
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Number of Symptomatic Intracranial Hemorrhage
Time Frame: Within 24 hours post-procedure
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Within 24 hours post-procedure
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Good Neurological Outcome at 90 Days
Time Frame: At 90 days post-procedure
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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
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At 90 days post-procedure
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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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLP 4853 (Other Identifier: Penumbrainc)
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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