Prospective Study on Safety and Efficacy of Stenting for Chronic Middle Cerebral Artery Occlusion With Limb Dysfunction

Huizhou Municipal Central Hospital

Status and phase: Completed; Early Phase 1

Conditions: Stenting Treatment; Modified Rankin Scale; National Institutes of Health Stroke Scale; Chronic Middle Cerebral Artery Occlusion

Treatments: Drug: standard treatment with aspirin.; Procedure: Middle Cerebral Artery Stent Implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06419283

LLBA201952A

Details and patient eligibility

About

The goal of this clinical study is to evaluate the safety and efficacy of stenting for revascularization treatment of chronic middle cerebral artery (MCA) occlusion in patients with chronic MCA occlusion.

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age and gender: individuals aged 18 and above, regardless of gender.
• 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

• Acute stroke: occurrence of an acute cerebrovascular event within the past three months.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups, including a placebo group

stenting group

Experimental group

Description:

Middle Cerebral Artery Stent Implantation

Treatment:

Procedure: Middle Cerebral Artery Stent Implantation

Drug: standard treatment with aspirin.

control group

Placebo Comparator group

Description:

standard treatment with aspirin.

Treatment:

Drug: standard treatment with aspirin.