Stroke Clinical Trial
Official title:
Interventional Management of Stroke Trial (IMS III): 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
The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset—combined intravenous (IV) and endovascular therapy and standard intravenous (IV) rt-PA alone.
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 an endovascular therapy 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. While information on device use was collected, individual device performance
was not a primary outcome.
Nine hundred participants with moderate to severe ischemic stroke will be enrolled at more
than 50 centers in the United States, Canada, Australia and Europe.
Subjects will be randomized in a 2:1 ratio to receive endovascular therapy or IV only with
adjustment for clinical site and NIHSSS strata. If enrolled under Amendment 5 or later both
treatment groups will receive the standard approved therapy dose of rt-PA (0.9 mg/kg, 90 mg
max) administered intravenously over one hour. The consent process and randomization can
take place prior to or anytime up to forty minutes after the IV bolus dose. If, at the 40
minute time point, no consent has been obtained or randomization has not been completed, the
patient will no longer be eligible for IMS III enrollment. After consent, the endovascular
therapy group will then undergo immediate angiography. If clot is not demonstrated, no more
treatment is administered.
If clot is demonstrated, the neurointerventionalist will then choose from currently
available but trial defined endovascular therapy approaches, choosing the treatment they
feel will be most effective in attempting to reopen the blocked artery. These approaches
utilize local regulatory, US FDA and IMS III Executive Committee approved devices for the
intra-arterial infusion of investigational rt-PA using standard microcatheter or the EKOS
Micro-Infusion Catheter® (in US) or embolectomy devices including the Concentric Retriever
Device®, the Penumbra System ™, or the Solitaire™ FR Revascularization Device. All devices
must be used per the manufacturer's instructions for use. Endovascular therapy, whether
initially with the Merci® Retriever, EKOS Micro-Infusion Catheter, Penumbra System™,
Solitaire™, a future device, or infusion of IA rt-PA via a standard microcatheter, must be
started within 5 hours and completed within 7 hours of symptom onset. The maximum dose of IA
rt-PA is 22mg (maximum 2 to 4 mg bolus and infusion at a rate of 10 mg/hr). Use of tandem
devices (i.e. EKOS Micro-Infusion Catheter, Merci Retriever®, Penumbra System™, or
Solitaire™) in a single case is a protocol violation. Only standard microcatheter rt-PA
infusion therapy may be administered following attempt with a device.
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 endovascular therapy to the
standard IV rt-PA approach.
Duration of the study for participants is approximately 12 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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