Actively Recruiting
Endovascular Treatment for Mild Ischemic Stroke Due to Acute Large Vessel Occlusion in the Anterior Circulation: A Multicenter Prospective Registry
Led by Wen-huo Chen · Updated on 2024-06-18
200
Participants Needed
9
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness and safety of emergency endovascular treatment (EVT) for patients who have a mild ischemic stroke caused by a blockage in a large blood vessel in the front part of the brain. This study focuses on patients identified through special brain blood flow imaging within 24 hours of stroke onset. It aims to explore EVT as a treatment option for this specific stroke type and severity. Participants may receive EVT chosen by the doctor based on their condition, which can include methods like stent retriever thrombectomy, aspiration thrombectomy, intra-arterial clot dissolving, balloon angioplasty, or stent placement. All patients receive the best medical care according to local standards during and after the procedure. The study has two groups: one receiving EVT plus standard care, and another receiving only standard medical treatment unless worsening occurs, in which case EVT may be given. During the study, participants will be monitored closely with clinical evaluations and imaging to assess their recovery. The main outcome measured is the rate of excellent recovery at about 90 days after treatment. Secondary outcomes include good recovery rates and shifts in disability scores measured at the same time. The study tracks safety and effectiveness for up to 90 days with follow-up assessments to understand the impact of the treatments.
CONDITIONS
Brief Title
Endovascular Treatment for Mild Ischemic Stroke Due to Acute Large Vessel Occlusion in the Anterior Circulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old
- Stroke symptoms or last known well time within 24 hours before randomization
- Clinical diagnosis of acute ischemic stroke due to anterior circulation large vessel occlusion confirmed by CTA or MRA
- Baseline NIHSS score less than 6 before randomization, including cases improved from 6 or higher
- ASPECTS score 6 or higher based on Non-contrast CT before randomization
You will not qualify if you...
- Premorbid Rankin Scale score 1 or higher
- Known allergy to iodine, heparin, anesthesia, or contraindication to endovascular treatment
- Severe or fatal co-morbidities interfering with assessments or with life expectancy less than 6 months
- Poorly controlled hypertension with systolic >220 mmHg or diastolic >120 mmHg
- Baseline blood glucose less than 50 mg/dL or more than 400 mg/dL
- Known bleeding tendency or recent anticoagulant therapy with abnormal coagulation tests
- Seizures at stroke onset or during course preventing accurate NIHSS scoring
- Female who is pregnant, breastfeeding, or positive pregnancy test at admission
- Currently in another investigational drug or device study affecting results
- Evidence of intracranial hemorrhage on imaging
- Significant brain midline shift or hernia on imaging
- Impossibility to complete endovascular treatment due to vascular issues
- Aortic dissection
- Multiple intracranial large vessel occlusions preventing clear identification of symptomatic vessel
- Suspected or confirmed non-acute occlusion of artery
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 24 hours before randomization
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Within 24 hours of stroke onset
Participants undergo endovascular treatment (EVT) if assigned to the experimental group, involving procedures such as stent retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, or stent implantation. Participants in the control group receive best medical treatment according to local standards without EVT, with remedial EVT if neurological deterioration occurs within 24 hours.
1 procedure visit (in-person)
Duration - Approximately 90 days
Participants are assessed for efficacy and safety outcomes, including neurological function and recovery status.
1 follow-up visit (in-person) around 90 days post treatment
Trial Site Locations
Total: 9 locations
1
Zhangzhou Municipal Hospital
Zhangzhou, Fujian, China, 363000
Actively Recruiting
2
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, Gansu, China, 730050
Actively Recruiting
3
Jiamusi Central Hospital
Jiamusi, Heilongjiang, China, 154000
Actively Recruiting
4
Ganzhou People's Hospital
Ganzhou, Jiangxi, China, 330000
Actively Recruiting
5
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
6
Songyuan Jilin Oilfield Hospital
Songyuan, Jilin, China, 138000
Actively Recruiting
7
Shenyang First People's Hospital
Shenyang, Liaoling, China
Actively Recruiting
8
Lishui Central Hospital
Lishui, Zhejiang, China, 310000
Actively Recruiting
9
Taizhou First People's Hospital
Taizhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
W
Wenhuo Chen, MD
T
Tingyu Yi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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