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

Early Phase 1

Completed

• Conditions: Modified Rankin Scale; Chronic Middle Cerebral Artery Occlusion; Stenting Treatment; National Institutes of Health Stroke Scale
• Interventions: Procedure: Middle Cerebral Artery Stent Implantation; Drug: standard treatment with aspirin.

• Registration Number: NCT06419283
• Lead Sponsor: Huizhou Municipal Central Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2022-12-01
• Study Completion: 2024-03-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-17
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stenting group	Middle Cerebral Artery Stent Implantation	Middle Cerebral Artery Stent Implantation
stenting group	standard treatment with aspirin.	Middle Cerebral Artery Stent Implantation
control group	standard treatment with aspirin.	standard treatment with aspirin.

Primary Outcome Measures

Name	Time	Method
the Modified Rankin Scale (mRS) scores	3 months	The Modified Rankin Scale (mRS) scores serve as a critical outcome measure to assess the effectiveness of stenting treatment for patients with chronic middle cerebral artery (MCA) occlusion. The mRS is a standardized instrument that evaluates the degree of disability or dependence in daily activities following a stroke. It ranges from 0 (no symptoms) to 6 (death), with a higher mRS score indicates a greater level of disability or dependence.
the National Institutes of Health Stroke Scale (NIHSS) scores	3 months	The National Institutes of Health Stroke Scale (NIHSS) scores：By quantifying the degree of neurological deficits in stroke patients before and three months after surgery, the efficacy and safety of stent implantation can be assessed. The NIHSS score includes multiple items, with higher scores indicating more severe functional impairments, ranging from a total score of 0 (no stroke) to 42 (severe stroke).

Trial Locations

Locations (1)

Huihong Huang; 🇨🇳 Huizhou, Guangdong, China