An interventional study of Intracranial stenting with Credo® stent in Intracranial Atherosclerosis, Stent Stenosis and Ischemic Stroke, sponsored by Can Tho Stroke International Services Hospital. Completed at 1 site in Vietnam. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Can Tho Stroke International Services Hospital · Not applicable, Interventional, and Prevention
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.
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.
102 studies on the registry are indexed under Intracranial Arteriosclerosis; 48 are open to participants now.
This study's enrollment of 156 is below the median of 194 across 61 interventional studies indexed under Intracranial Arteriosclerosis.
Browse Intracranial Arteriosclerosis studies →Can Tho Stroke International Services Hospital is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Symptomatic ischemic stroke patients were treated with Credo® Stent
Procedure: Intracranial stenting with Credo® stent
Symptomatic ischemic stroke patients were treated with Credo® Stent
Rate of the critical adverse events
The critical adverse events: intracranial hemorrhage, new infarct
Time frame: After procedure within 24 hours
Rate of 1-year recurrent ischemic stroke
Rate of 1-year recurrent ischemic stroke in the territory of the symptomatic intracranial artery
Time frame: During 1 year after procedure
Plan to share: No
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Intracranial Arteriosclerosis →
Can Tho Stroke International Services Hospital