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OpenTrials
Completed

NCT Number: NCT05947994

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

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Can Tho Stroke International Service General Hospital

Can Tho, 900000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intracranial stenting with Credo® stent

Procedure

Symptomatic ischemic stroke patients were treated with Credo® Stent

Primary outcomes

  1. Rate of the critical adverse events

    Time frame: After procedure within 24 hours

    The critical adverse events: intracranial hemorrhage, new infarct

  2. Rate of 1-year recurrent ischemic stroke

    Time frame: During 1 year after procedure

    Rate of 1-year recurrent ischemic stroke in the territory of the symptomatic intracranial artery

Sponsors and collaborators

Lead sponsor

Can Tho Stroke International Services Hospital

Other

Collaborators

  • Acandis GmbH

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 17, 2023
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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