Credo Stent in the Symptomatic Intracranial Stenosis

Study Overview
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Brief Summary
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In the symptomatic ischemic stroke, the decision-making of medical treatment plus intracranial stenting (IS) has been more and more popular, especially in patients with intracranial large severe stenosis or occlusive artery. Nonetheless, there were few evidences evaluating the comprehensive information of the other self-expanding stent relating IS procedure after positive results of the Wingspan Stent System Post Market Surveillance (WEAVE) trial and Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN) study about Wingspan stent. The aim of our study was to investigate whether IS with Credo stent would improve the adverse events 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 (IS) in the low risk of periprocedural stroke or death. However, this conclusion has influenced the role of IS in the secondary prevention of ischemic stroke and recovery time for a long time because of the improper patient selection of this trial such as no evidence of medical failure, IS in case of moderate intracranial stenosis and IS in patients with transient ischemic attacks only. Recently, the Food and Drug Administration (FDA) mandated study about IS, 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 with Wingspan stent (Stryker, Kalamazoo, MI) in the world and a paucity of evidence from the comprehensive stroke centers about other self-expanding stents, Credo stent (Acandis GmbH, Pforzheim, Germany), our purpose was to evaluate the periprocedural events associating to the IS.

Official Title
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CREdo Stent in the Symptomatic Intracranial Stenosis

Conditions
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Stent Stenosis, Intracranial Atherosclerosis, Ischemic Stroke

Intervention / Treatment
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* Procedure: Intracranial stenting
* Device: Credo® Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Evidence of severe intracranial stenosis Target intracranial artery ≥ 2 mm Absence of intracranial hemorrhage Procedure treated with the Credo stent (Acandis, Pforzheim, Germany) Exclusion Criteria: Premorbid modified Rankin Scale (mRS) score ≥ 2 Intracranial rescue stenting for acute ischemic stroke within 24 hours Loss to follow-up after discharge Systemic lupus erythematosus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracranial stenting with Credo® Stent<br>Symptomatic ischemic stroke patients were treated with Credo® Stent | Procedure: Intracranial stenting<br>* Symptomatic ischemic stroke patients were treated with Credo® Stent<br>Device: Credo® Stent<br>* A self-expanding stent is used intracranial stenting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of stroke of the qualifying lesion in the territory of the symptomatic intracranial artery | Stroke: new infarcts, intracranial hemorrhage, subarachnoid hemorrhage | During 1 year after procedure | 
| Rate of death of the qualifying lesion in the territory of the symptomatic intracranial artery | Rate of death of the qualifying lesion in the territory of the symptomatic intracranial artery | During 1 year after procedure | 

Secondary 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 procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic stroke, Intracranial Atherosclerosis, Intracranial stenting