Elucidate Outcomes of Elective High-grade/Total Occlusion Intracranial Arteries Using Low-profile Self-expanding Stent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-04-20

Brief Summary

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Intracranial atherosclerotic disease (ICAD) is a high prevalent cause of stroke, especially in Asian population and can be categorized as either symptomatic (resulting in acute ischemic stroke) or asymptomatic. Treatment for patients who failed with optimal medical therapy (OMT) is still elucidating.

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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, the Wingspan Stent System Post Market Surveillance (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 Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN) study about Wingspan stent (Stryker, Kalamazoo, MI). 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 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 compare the periprocedural complication and rate of 1-year recurrent ischemic stroke associating to the IS between beyond 7 days from acute stage and the progressive ischemic stroke time.

Conditions

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Intracranial Atherosclerosis Stent Stenosis Ischemic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Optimal medical therapy failure

Symptomatic ischemic stroke patients were treated with Credo® Stent

Group Type EXPERIMENTAL

Intracranial stenting with Credo® stent

Intervention Type PROCEDURE

Symptomatic ischemic stroke patients were treated with Credo® Stent

Interventions

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Intracranial stenting with Credo® stent

Symptomatic ischemic stroke patients were treated with Credo® Stent

Intervention Type PROCEDURE

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
* More procedures at the same time

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes