Evaluation of the Safety and Efficacy of Stenting for Chronic Middle Cerebral Artery Occlusion With Limb Dysfunction: a Prospective Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- the Modified Rankin Scale (mRS) scores
研究概览
简要总结
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:
- Whether stenting treatment can improve blood flow restoration in chronic MCA occlusion.
- If stenting can reduce the rates of reocclusion.
- 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:
- Undergo full cerebral angiography to identify the occlusion site.
- 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.
- Participants will be followed up for three months post-treatment to assess the long-term efficacy and safety of the stenting procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
stenting group
Middle Cerebral Artery Stent Implantation
干预措施: Middle Cerebral Artery Stent Implantation (Procedure)
stenting group
Middle Cerebral Artery Stent Implantation
干预措施: standard treatment with aspirin. (Drug)
control group
standard treatment with aspirin.
干预措施: standard treatment with aspirin. (Drug)
结局指标
主要结局
the Modified Rankin Scale (mRS) scores
时间窗: 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.
the National Institutes of Health Stroke Scale (NIHSS) scores
时间窗: 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).
次要结局
未报告次要终点