Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy

Phase 2

Completed

Conditions: Stroke

Interventions: Device: Merci Retriever and Penumbra System

Registration Number: NCT00389467

Lead Sponsor: University of California, Los Angeles

Brief Summary: The purpose of this study is to compare the effectiveness of treating acute ischemic stroke with mechanical embolectomy using the Merci Retriever or the Penumbra System within 8 hours of symptom onset to standard medical treatment, and to identify people who might benefit from mechanical embolectomy by the appearance of stroke on multimodal computerized tomography (CT) or magnetic resonance (MR) imaging.

Detailed Description: Stroke most commonly occurs when there is a blockage of blood flow to one of the arteries in the brain. The blockage is often caused by a clot. There is currently only one FDA-approved stroke treatment. However, only 2 percent of ischemic stroke patients receive this treatment because it must be given within 4.5 hours of the stroke onset. There is an overwhelming need for new treatments that extend the time window to treatment since most individuals with stroke arrive at the hospital after the 4.5-hour time window.

Two of the most promising new devices are the Merci Retriever, a tiny corkscrew device, and the Penumbra System, an aspiration device. Both are designed to remove clots from arteries and thereby restore blood flow to the brain.

The primary purpose of this study is to compare the effectiveness of treatment with the Merci Retriever or Penumbra System within 8 hours of symptom onset to standard medical treatment, and to identify people who might benefit from the devices by the appearance of the stroke on multimodal computerized tomography (CT) or magnetic resonance imaging (MRI). Previous testing has determined that the use of the Merci Retriever is successful in opening up blocked blood vessels in approximately ½ of the individuals in whom it is used, and the Penumbra System is successful in opening up blocked blood vessels in approximately 80% of the individuals in whom it is used.

A total of 120 participants from approximately 30 different medical centers will be enrolled into this study. Participants will be randomized to either receive treatment by mechanical embolectomy with the Merci Retriever or Penumbra System and standard medical care or treatment with standard medical care alone. Standard care for stroke patients may include intravenous fluid, careful regulation of blood pressure, blood-thinning medicine (such as heparin or warfarin), anti-platelet medicine (such as aspirin or clopidogrel), and rehabilitation therapies.

Participants undergoing the Merci Retriever or Penumbra System procedure will have a cerebral arteriogram with pictures taken with dye prior to the procedure to determine the location of the blockage, and following the procedure to determine if blood supply has been restored. The total mechanical embolectomy procedure with either device will take approximately 1 to 2 hours. Participants will have brief neurological exams several times during this time to monitor changes in their neurological condition.

Participants will have follow-up visits, including neurological exams, at 30 days and at 90 days.

This study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients by treating more patients in less than 2 hours, and finding ways to treat additional patients later.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 127

Inclusion Criteria

New focal disabling neurologic deficit consistent with acute cerebral ischemia (NIHSS >/= 6)
Age >/= 18 ≤ 85
Clot retrieval procedure can be initiated within 8 hours from onset
Large vessel proximal anterior circulation occlusion on MR or CT angiography (internal carotid, M1 or M2 MCA)
Pretreatment MRI performed according to MR RESCUE protocol
Signed informed consent obtained from the patient or patient's legally authorized representative
Premorbid modified Rankin score of 0-2
Allowed but not required: patients treated with IV tPA (tissue plasminogen activator) up to 4.5 hours from symptom onset with persistent target occlusion on post-treatment MR RESCUE MR or CT protocol performed at the completion of drug infusion (Note: Rapidly improving neurological signs prior to randomization is an exclusion)

Exclusion Criteria

NIHSS >/= 30
Contraindication to MRI (pacemaker etc)
Acute intracranial hemorrhage
Coma
Rapidly improving neurological signs prior to randomization
Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations
Pregnancy
Known allergy to iodine previously refractory to pretreatment medications
Current participation in another experimental treatment protocol
Contrast-Enhanced Neck MRA (magnetic resonance angiography) or CTA (computed tomography angiography) suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection
INR > 3.0 (international normalized ratio)
PTT > 3 x Normal (partial thromboplastin time)
Imaging data cannot be processed by the MR RESCUE computer
Renal Failure (serum creatinine > 2.0 or Glomerular Filtration Rate [GFR] < 30)

MRI Exclusion Criteria:

Contraindication to MRI (pacemaker, etc)

CT Exclusion Criteria:

Contraindication to iodinated contrast**

**Examples of possible iodinated contrast contraindications include:
Hyperthyroidism
History of severe allergic reaction to iodinated contrast material
History of sever kidney disease as an adult, including tumor or transplant surgery, or family history of kidney failure
Paraproteinemia syndromes or multiple myeloma
Collagen vascular disease
Severe cardiac insufficiency
Severely compromised liver function
Current therapy with metformin, aminoglycosides

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Mechanical Embolectomy	Merci Retriever and Penumbra System	Participants will be randomized to receive mechanical embolectomy treatment either with the Merci Retriever or Penumbra System and standard medical care or treatment with standard medical care alone.

Primary Outcome Measures

Name	Time	Method
The Modified Rankin Scale Score	at 90 days post-stroke	Scale name is provided (Modified Rankin Scale) which is a standard measure of functional neurologic outcome in stroke. The scale runs from 0-6, running from perfect health without symptoms to death. * 0 - No symptoms. * 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. * 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. * 3 - Moderate disability. Requires some help, but able to walk unassisted. * 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. * 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. * 6 - Dead.

Secondary Outcome Measures

Name	Time	Method
Day 90 Mortality	at day 90
Symptomatic Hemorrhagic Transformation	from baseline to day 7	Symptomatic intracranial hemorrhage is defined as 4 point neurologic worsening on the National Institutes of Health Stroke Scale (NIHSS) score associated with parenchymal hematoma type 2 (PH-2\), remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage on imaging. The NIHSS is a scale measuring specific neurologic deficits caused by a stroke with scores ranging from 0 to 42, and higher scores indicating more severe neurologic deficits. \from the modified European Cooperative Acute Stroke Study (ECASS) II criteria

Trial Locations

Locations (22): University of California at Los Angeles, UCLA Stroke Network, 924 Westwood Blvd #300
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Los Angeles, California, United States
St. Louis University Hospital, 3635 Vista Avenue at Grand Boulevard Saint Louis, MO
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St. Louis, Missouri, United States
West Virginia University 1 Medical Center, Morgantown WV 26506
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Morgantown, West Virginia, United States
Boston University, One Boston Medical Center Place, Department of Neurology, C329
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Boston, Massachusetts, United States
Georgetown University, Georgetown University Hospital, Room GG012, Ground Floor Gorman, 3800 Reservoir Road, NW
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Washington, District of Columbia, United States
University of California at San Diego, UCSD Medical Center, 200 W. Arbor Drive, OPC, 3rd Floor Suite 3
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San Diego, California, United States
University of Miami 1400 NW 10th Street, 10th Floor, Miami FL 33136
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Miami, Florida, United States
University of Cincinnati, Department of Neurology, University of Cincinnati Medical Center, 231 Albert Sabin Way, Medical Sciences Bldg, Rm 4015, PO Box 670525
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Cincinnati, Ohio, United States
Kaiser Permanente Los Angeles Medical Center 4867 W Sunset Blvd., Los Angeles CA 90027
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Los Angeles, California, United States
Cedars Sinai Medical Center 8700 Beverly Blvd., Los Angeles CA 90048
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Los Angeles, California, United States
Santa Monica-UCLA Medical Center, 1225 15th Street Santa Monica, CA 90404
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Santa Monica, California, United States
Washington Hospital Center, 110 Irving Street, NW, Washington, DC 20010
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Washington, District of Columbia, United States
University of Iowa Hospitals and Clinics, 200 Hawkins Dr, Iowa City, IA 52242
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Iowa City, Iowa, United States
Massachusetts General Hospital, 101 Huntington Ave Ste 300
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Boston, Massachusetts, United States
Cornell University, New York Presbyterian Hospital, Cornell Campus, 525 East 68th St, Box 141
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New York, New York, United States
Columbia University, 710 W 168th St, NI 551, ,
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New York, New York, United States
University of Pittsburgh, PUHC-426, 200 Lothrop Street
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Pittsburgh, Pennsylvania, United States
Chattanooga Center for Neurologic Research
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Chattanooga, Tennessee, United States
University of Calgary
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Calgary, Alberta, Canada
University of Texas at Houston, University of Texas, Houston Stroke Program, Department of Neurology, 6431 Fannin Street, MSB 7044
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Houston, Texas, United States
Suburban Hospital, 8600 Old Georgetown Road, Bethesda, MD 20814
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Bethesda, Maryland, United States
Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC 29403
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Charleston, South Carolina, United States