Chronic Middle Cerebral Artery OcclusionEarly Phase 1NCT06419283
Prospective Study on Safety and Efficacy of Stenting for Chronic Middle Cerebral Artery Occlusion With Limb Dysfunction
A Early Phase 1 study testing Middle Cerebral Artery Stent Implantation and standard treatment with aspirin. in people with Chronic Middle Cerebral Artery Occlusion and Stenting Treatment, run by Huizhou Municipal Central Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Middle Cerebral Artery Occlusion, Stenting Treatment, Modified Rankin Scale
- What is being tested?
- Middle Cerebral Artery Stent Implantation and standard treatment with aspirin.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 1 Mar 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Chronic Middle Cerebral Artery Occlusion, Stenting Treatment, Modified Rankin Scale, National Institutes of Health Stroke Scale
- Being tested
- Middle Cerebral Artery Stent Implantation, standard treatment with aspirin.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle Cerebral Artery Stent ImplantationProcedure or surgery
Middle Cerebral Artery Stent Implantation
standard treatment with aspirin.Drug
standard treatment with aspirin.
| Study group | Role | What they receive |
|---|---|---|
| stenting group | Experimental | Middle Cerebral Artery Stent Implantation Receives: Procedure: Middle Cerebral Artery Stent Implantation; Drug: standard treatment with aspirin. |
| control group | Placebo comparator | standard treatment with aspirin. Receives: Drug: standard treatment with aspirin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Aug 2019
- Primary completion1 Dec 2022
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Middle Cerebral Artery OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huizhou Municipal Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419283
- Sponsor's protocol ID
- LLBA201952A
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Stenting for Chronic Middle Cerebral Artery Occlusion With Limb Dysfunction: a Prospective Study
- ClinicalTrials.gov ID
- NCT06419283
- Acronym / sponsor ID
- LLBA201952A
- Conditions
- Chronic Middle Cerebral Artery Occlusion, Stenting Treatment, Modified Rankin Scale, National Institutes of Health Stroke Scale
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Huizhou Municipal Central HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stenting group | Experimental | Procedure: Middle Cerebral Artery Stent Implantation, Drug: standard treatment with aspirin.Middle Cerebral Artery Stent Implantation |
| control group | Placebo comparator | Drug: standard treatment with aspirin.standard treatment with aspirin. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Middle Cerebral Artery Stent ImplantationMiddle Cerebral Artery Stent Implantation | Procedure or surgery | stenting group |
| standard treatment with aspirin.standard treatment with aspirin. | Drug | control group, stenting group |
Primary outcome
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Middle Cerebral Artery Occlusion
Recruiting
Extracranial-intracranial Bypass Surgery for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial
Symptomatic Chronic Middle Cerebral Artery Occlusion, Infarction, Middle Cerebral Artery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Middle Cerebral Artery Stent Implantation and standard treatment with aspirin. in people with Chronic Middle Cerebral Artery Occlusion and Stenting Treatment, run by Huizhou Municipal Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Modified Rankin Scale (mRS) scores (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.