Credo Stent in the Symptomatic Intracranial Stenosis — CRESIS  

Ischemic Stroke Clinical Trial

Official title: Credo Stent in the Symptomatic Intracranial Stenosis: an Initial Vietnamese Study

Status Completed

Clinical Trial Summary

In the 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 were few evidences about times of intracranial stenting which compared beyond 7 days from acute ischemic stroke with the progressive ischemic stroke time. The purpose of this study was to compared the adverse events during 1-year follow-up of these two groups.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Atherosclerosis
• Constriction, Pathologic
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Ischemic Stroke
• Stent Stenosis

• NCT number: NCT05947994
• Study type: Interventional
• Source: Can Tho Stroke International Services Hospital
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Completion date: April 20, 2024