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

May 15, 2024 updated by: Huizhou Municipal Central Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the Modified Rankin Scale (mRS) scores
Time Frame: 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.
3 months
the National Institutes of Health Stroke Scale (NIHSS) scores
Time Frame: 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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huizhou Municipal Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings