Prospective Study on Safety and Efficacy of Stenting for Chronic Middle Cerebral Artery Occlusion With Limb Dysfunction
NCT ID: NCT06419283
Last Updated: 2024-05-17
Study Results
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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COMPLETED
EARLY_PHASE1
59 participants
INTERVENTIONAL
2019-08-01
2024-03-01
Brief Summary
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The main questions it aims to answer are:
1. Whether stenting treatment can improve blood flow restoration in chronic MCA occlusion.
2. If stenting can reduce the rates of reocclusion.
3. How stenting affects the recovery of neurological functions in these patients.
Researchers will compare the stenting group, which received stenting revascularization in addition to aspirin treatment, to the control group, which received only aspirin treatment to see if stenting treatment provides superior outcomes in terms of neurological function improvement and safety profile.
Participants will:
1. Undergo full cerebral angiography to identify the occlusion site.
2. All participants will be monitored for post-procedure complications and neurological function using the Modified Rankin Scale (mRS) and National Institutes of Health Stroke Scale (NIHSS) before and after treatment.
3. Participants will be followed up for three months post-treatment to assess the long-term efficacy and safety of the stenting procedure.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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stenting group
Middle Cerebral Artery Stent Implantation
Middle Cerebral Artery Stent Implantation
Middle Cerebral Artery Stent Implantation
standard treatment with aspirin.
standard treatment with aspirin.
control group
standard treatment with aspirin.
standard treatment with aspirin.
standard treatment with aspirin.
Interventions
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Middle Cerebral Artery Stent Implantation
Middle Cerebral Artery Stent Implantation
standard treatment with aspirin.
standard treatment with aspirin.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis: chronic MCA occlusion confirmed by imaging studies (such as Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)) for more than 3 months.
* Symptoms: neurological deficits caused by MCA occlusion, such as hemiplegia, speech disorders, etc.
* Treatment History: no stenting revascularization for MCA occlusion within the past three months.
Exclusion Criteria
* Other significant diseases: such as severe heart disease, liver or kidney dysfunction, cerebral hemorrhage, active bleeding, or coagulation disorders.
* Allergy to contrast agents.
* Severe mental illness or inability to comply with study requirements.
* Pregnant or breastfeeding women.
* Discovery of MCA occlusion without any symptoms.
* Participation in other clinical trials within the past six months.
18 Years
99 Years
ALL
No
Sponsors
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Huizhou Municipal Central Hospital
OTHER
Responsible Party
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Locations
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Huihong Huang
Huizhou, Guangdong, China
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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LLBA201952A
Identifier Type: -
Identifier Source: org_study_id
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