NCT06419283CompletedEarly phase 1
Prospective Study on Safety and Efficacy of Stenting for Chronic Middle Cerebral Artery Occlusion With Limb Dysfunction
Evaluation of the Safety and Efficacy of Stenting for Chronic Middle Cerebral Artery Occlusion With Limb Dysfunction: a Prospective Study
Source: ClinicalTrials.gov · Last updated 17 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 59 (actual)
- First submitted
- 7 May 2024
- Start date
- 1 Aug 2019
- Primary completion date
- 1 Dec 2022
- Lead sponsor
- Huizhou Municipal Central Hospital
- Diseases
- Stroke
- NCT number
- NCT06419283
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 59
- From 1 Aug 2019 to the primary completion date, 1 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Pregnant or breastfeeding women.
- Discovery of MCA occlusion without any symptoms.
- Participation in other clinical trials within the past six months.
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huihong Huang Coordinator of this site? Confirm its status | Huizhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.