Intracranial Stenting in Non-acute Symptomatic Ischemic Stroke

Study Overview
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Brief Summary
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In non-acute symptomatic ischemic stroke, the decision-making of medical treatment plus intracranial stenting has been more and more popular, especially in patients with intracranial large severe stenosis or occlusive artery. Nonetheless, there is no evidence from randomized controlled trials evaluating the efficacy of this treatment after the Wingspan Stent System Post Market Surveillance (WEAVE) and Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN) trial compared with medical treatment alone. This trial was to investigate whether medical treatment plus intracranial stenting would prevent the recurrent ischemic stroke in the territory of the symptomatic intracranial artery during 1-year follow-up.

Detailed Description
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In symptomatic ischemic stroke due to intracranial large severe stenosis or occlusive artery, the choice for treatment has remained controversial after results of the Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial because it demonstrated that the efficacy of medical treatment was superior to intracranial stenting in the low risk of periprocedural stroke or death. However, this conclusion has influenced the role of intracranial stenting in the ischemic stroke treatment and recovery time for a long time because of the unproper patient selection of this trial such as no evidence of medical failure, intracranial stenting earlier than 7 days after the stroke and intracranial stenting in patients with transient ischemic attacks only. Recently, the Food and Drug Administration (FDA) mandated study about intracranial stenting, WEAVE trial, reported not only 97.4% patients with no complication at 72 hours, but also a relatively low 8.5% recurrent stroke and death rate during 1 year in the WOVEN study. In case of the symptomatic stenosis greater than 70%, the probability of recurrent stroke and transient ischemic attack in the territory of the symptomatic stenotic artery in 1 year was 23% and 14%, respectively, despite treatment with antithrombotic therapy and standard management of vascular risk. Given a lot of patients with symptomatic ischemic stroke who have some adjustable indications for intracranial stenting deployment in the world and a paucity of evidence from randomized trials, the purpose of this trial was to compare this treatment versus medical one in the intracranial large severe stenosis or occlusive artery.

Official Title
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Intracranial Stenting in Non-acute Symptomatic Ischemic Stroke: an Open-label, Randomised Controlled Trial

Conditions
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Intracranial Arteriosclerosis, Ischemic Stroke, Intracranial Arterial Diseases, Arterial Occlusive Diseases

Intervention / Treatment
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* Procedure: Medical treatment plus intracranial stenting
* Drug: Medical treatment alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Evidence of intracranial large severe stenosis or occlusive artery in angiography. Absence of intracranial hemorrhage. Premorbid mRS score is ≤ 3. Recurrent stroke in the target territory during the medical treatment for ischemic stroke prevention. Exclusion Criteria: Tandem lesion. Loss to follow-up after discharge. A severe or fatal combined illness before acute ischemic stroke. Progressive neurologic deficit within 7 days after acute ischemic stroke. Large middle cerebral artery infarct within 30 days after acute ischemic stroke.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical treatment plus intracranial stenting (MT plus IS)<br>This group will be both given medical treatment (aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter) and performed with intracranial stenting. | Procedure: Medical treatment plus intracranial stenting<br>* This group will be both given medical treatment (aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter) and performed with intracranial stenting.<br>* Other names: MT plus IS;|
| Active Comparator: Medical treatment alone (MT)<br>This group will be given medical treatment including aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter. | Drug: Medical treatment alone<br>* This group will be given medical treatment including aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter.<br>* Other names: MT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery. | Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery. | During 1 year after randomization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death rate of the qualifying lesion in the territory of the symptomatic intracranial artery. | Death rate of the qualifying lesion in the territory of the symptomatic intracranial artery. | During 1 year after randomization. | 
| Rate of ischemic stroke recovery of the qualifying lesion in the territory of the symptomatic intracranial artery. | Rate of ischemic stroke recovery of the qualifying lesion in the territory of the symptomatic intracranial artery was accessed by modified Rankin Score (mRS). | During 3 months after randomization.. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dual antiplatelet therapy, MRI 3 Tesla, WEAVE trial, WOVEN trial