Credo Stent in the Symptomatic Intracranial Stenosis — CRESIS  

Ischemic Stroke Clinical Trial

Official title: CREdo Stent in the Symptomatic Intracranial Stenosis

Status Recruiting

Clinical Trial Summary

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.

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, 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. ;

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
• Contact: Cuong C Tran, PhD
• Phone: +84886559911
• Email: drcuongtran@dotquy.vn
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Completion date: October 1, 2024