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NCT Number: NCT06419283

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

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Huihong Huang

Huizhou, Guangdong, 516001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Middle Cerebral Artery Stent Implantation

Procedure

Middle Cerebral Artery Stent Implantation

standard treatment with aspirin.

Drug

standard treatment with aspirin.

Primary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Huizhou Municipal Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2024
First posted
May 17, 2024
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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