Interventional Management of Stroke (IMS) III Trial



Status:Archived
Conditions:Peripheral Vascular Disease, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:Any
Updated:7/1/2011

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Interventional Management of Stroke Trial: A Phase III Clinical Trial Examining Whether a Combined Intravenous (IV) and Intra-Arterial (IA) Approach to Recanalization is Superior to Standard IV Rt-PA (Activase®) Alone When Initiated Within Three Hours of Acute Ischemic Stroke Onset


The purpose of this study is to compare two different treatment approaches—combined
intravenous and intra-arterial treatment including recombinant tissue plasminogen activator
(rt-PA) and standard intravenous (IV) rt-PA—to restoring blood flow to the brain.


Stroke remains a major cause of death and disability. Acute thrombolytic therapy offers the
potential to achieve early recanalization (reopening of blocked arteries), save tissues, and
improve outcome. Currently, intravenous (IV) recombinant tissue plasminogen activator
(rt-PA) is the only approved acute stroke therapy. IV rt-PA is an effective therapy for
acute ischemic stroke but has substantial limitations when used alone to open blocked
arteries The Interventional Management of Stroke (IMS III) Trial is a multi-center study
that will compare two different treatment approaches for restoring blood flow to the brain.
One approach, giving the clot-dissolving drug rt-PA, is already FDA-approved when given
through a vein (IV). This treatment will be compared to a new approach, giving rt-PA at a
lower dose first through IV in the arm and then, if a blood clot in the brain artery is
found, through a small tube or catheter at the site of the blood clot (intra-arterial or IA)
to see which is better. Both approaches must be initiated within three hours of stroke
onset.

The primary goal of this trial is to determine if individuals with ischemic stroke treated
with rt-PA using a combined IV/IA approach to recanalization started within 3 hours of onset
are more likely to have a better outcome than individuals treated with standard IV rt-PA
alone.

Nine hundred participants with moderate to severe ischemic stroke will be enrolled at more
than 50 centers in the United States, Canada, and Australia. Participants will be assigned
randomly to one of 2 groups. Two participants will be randomized to the combined approach
for every one participant randomized to standard IV rt-PA. Group one will receive the
standard dose of IV rt-PA given over an hour. Group two will receive the standard dose of
IV rt-PA for only 40 minutes and then undergo an angiogram test (cerebral angiography) right
after the medicine is given to check for blood clots. If a clot is not seen then no more
treatment will be given. If a clot is seen, the doctor (a neurointerventionalist) will then
choose, based on the location and extent of the blood clot, one of 4 possible IA treatments
given directly in the brain artery that will be most effective in reopening the blocked
artery. All of the IA treatments used—embolectomy therapy with either the Merci® Retriever
or The Penumbra System™, or rt-PA infusion through the EKOS® Micro-Infusion Catheter,
concurrent with delivery of low-intensity ultrasound energy, or infusion of rt-PA though a
standard microcatheter at the site of the blood clot in the brain artery.

The primary measure of benefit in this trial is the ability of the individual with stroke to
live and function independently 3 months after the stroke. This trial will also determine
and compare the safety and cost effectiveness of the combined IV/IA approach to the standard
IV rt-PA approach.

Duration of the study for participants is approximately 12 months.


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Fairfield, Ohio 45014
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300 Pinellas St.
Clearwater, Florida 33756
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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Sarasota, Florida 34232
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Asheville, North Carolina 28801
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Boston, Massachusetts 02135
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Burlington, Maine 01805
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101 Manning Dr
Chapel Hill, North Carolina 27599
(919) 966-4131
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlottesville, Virginia 22903
(434) 924-0311
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Cincinnati, Ohio 45219
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Cincinnati, Ohio 45219
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Cincinnati, Ohio 45236
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Cincinnati, Ohio 45239
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Cincinnati, Ohio 45238
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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East Lansing, Michigan 48824
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Elk Grove Village, Illinois 60007
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Ft. Thomas, Kentucky 41075
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
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530 S Jackson St
Louisville, Kentucky 40202
502-562-3226
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
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New Britain, Connecticut 06052
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Newport Beach, California 92663
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Phoenix, Arizona 85054
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Phoenix, Arizona 85013
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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Pittsburgh, Pennsylvania 15212
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601 Elmwood Ave
Rochester, New York 14642
(585) 275-2100
Strong Memorial Hospital (University of Rochester School of Medicine) In addition to offering traditional and...
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Santa Monica, California 90404
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St. Louis, Missouri 63110
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St. Paul, Minnesota 55102
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