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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Huizhou, Guangdong, China, 516001
      • Huihong Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stenting group; Middle Cerebral Artery Stent Implantation	Procedure: Middle Cerebral Artery Stent Implantation; Middle Cerebral Artery Stent Implantation; Drug: standard treatment with aspirin.; standard treatment with aspirin.
Placebo Comparator: control group; standard treatment with aspirin.	Drug: standard treatment with aspirin.; standard treatment with aspirin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Huizhou Municipal Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Stroke; Brain Infarction; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebral Infarction; Arterial Occlusive Diseases; Infarction, Middle Cerebral Artery; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: LLBA201952A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No