Prospective Study on Safety and Efficacy of Stenting for Chronic Middle Cerebral Artery Occlusion… (NCT06419283) | Clinical Trial Compass
CompletedEarly Phase 1
Prospective Study on Safety and Efficacy of Stenting for Chronic Middle Cerebral Artery Occlusion With Limb Dysfunction
China59 participantsStarted 2019-08-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the Modified Rankin Scale (mRS) scores
Timeframe: 3 months
2
the National Institutes of Health Stroke Scale (NIHSS) scores