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

NCT06419283 | Completed Early Phase 1

• 1 other identifier: LLBA201952A
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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. 1.Whether stenting treatment can improve blood flow restoration in chronic MCA occlusion.
2. 2.If stenting can reduce the rates of reocclusion.
3. 3.How stenting affects the recovery of neurological functions in these patients.
4. 4.Undergo full cerebral angiography to identify the occlusion site.
5. 5.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.
6. 6.Participants will be followed up for three months post-treatment to assess the long-term efficacy and safety of the stenting procedure.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

stenting group

EXPERIMENTAL

Middle Cerebral Artery Stent Implantation

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

control group

PLACEBO COMPARATOR

standard treatment with aspirin.

Drug: standard treatment with aspirin.

Interventions

Middle Cerebral Artery Stent Implantation PROCEDURE

Middle Cerebral Artery Stent Implantation

stenting group

standard treatment with aspirin. DRUG

standard treatment with aspirin.

control group; stenting group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huizhou Municipal Central Hospital: lead

Study Sites (1)

Huihong Huang

Huizhou, Guangdong, 516001, China

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 17, 2024
• Study Start: August 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)