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

National Institutes of Health Stroke Scale Clinical Trial

Official title:

Evaluation of the Safety and Efficacy of Stenting for Chronic Middle Cerebral Artery Occlusion With Limb Dysfunction: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06419283
• Other study ID #: LLBA201952A
• Status: Completed
• Phase: Early Phase 1
• Start date: August 1, 2019
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2024
• Source: Huizhou Municipal Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 1, 2024
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Infarction, Middle Cerebral Artery
• National Institutes of Health Stroke Scale

Intervention

Procedure:
• Middle Cerebral Artery Stent Implantation
Middle Cerebral Artery Stent Implantation

Drug:
• standard treatment with aspirin.
standard treatment with aspirin.

Locations

Country	Name	City	State
China	Huihong Huang	Huizhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Huizhou Municipal Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Modified Rankin Scale (mRS) scores	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.	3 months
Primary	the National Institutes of Health Stroke Scale (NIHSS) scores	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).	3 months