Clinical trial NCT06179017: Endovascular Treatment for Mild Stroke With Acute Anterior Circulation Large Vessel Occlusion
Official title: Endovascular Treatment for Mild Stroke With Acute Anterior Circulation Large Vessel Occlusion：a Multicenter Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endovascular Treatment
Keywords: Acute Ischemic Stroke
Lead sponsor: Zhangzhou Municipal Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: The Affiliated Hospital Of Guizhou Medical University
First posted: 2023-12-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group: Endovascular treatment Control group:Best medical treatment
Primary purpose: TREATMENT

Brief summary: Exploring the Efficacy and Safety of Emergent Endovascular Treatment in Patients with Mild Ischemic Stroke Caused by Acute Anterior Circulation Large Vessel Occlusion based on Perfusion Imaging Screening

Detailed description: This study aims to select suitable patients with mild AIS caused by anterior circulation LVO with mismatch volume of the ischemic penumbra based on screen of cerebral perfusion imaging. It is a prospective, multicenter, endpoint-blinded, randomized controlled trial design, and aim to explore the efficacy and safety of EVT for mild AIS patients with anterior circulation large vessel occlusion within 24 hours of onset.

Eligibility criteria: Inclusion Criteria Inclusion Criteria

1. Age 18-80 years old;
2. Symptoms onset or last known well to randomization is within 24 hours.
3. Clinical diagnosis of acute ischemic stroke due to anterior circulation intracranial large vessel occlusion (LVO) (including intracranial internal carotid artery \[ICA\], middle cerebral artery \[MCA\] M1 segment, MCA M2 segment, with or without ipsilateral extracranial ICA occlusion) confirmed on Computerized tomography angiography (CTA) or Magnetic resonance imaging angiography (MRA) ;
4. Baseline NIHSS score \<6 before randomization (including cases with NIHSS ≥6 at onset but improves before randomization);
5. ASPECTS score ≥6 based on Non-contrast CT (NCCT) before randomization, and computerized tomography perfusion (CTP) or magnetic resonance imaging perfusion (MRP) imaging presented infarct core volume (relative cerebral blood flow (rCBF) \<30%/DWI-ADC\<620) ≤50ml, and mismatch volume (Tmax\>6 seconds volume - rCBF \<30% /DWI-ADC\<620) ≥50mL;
6. The patient or their legal representatives voluntarilysigned the informed consent form.

Clinical Exclusion Criteria

1. Premorbid Rankin Scale (mRS) score ≥ 1;
2. Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure;
3. Patient has severe or fatal co-morbidities that could interfere with outcome assessments and follow-up (such as malignant tumor, severe heart failure, or renal failure, or life expectancy less than 6 months);
4. Poorly controlled hypertension (systolic blood pressure \>220 mmHg or diastolic blood pressure \>120 mmHg);
5. Baseline blood glucose \<50mg/dL (2.78 mmol/L) or \>400mg/dL (22.20 mmol/L);
6. Known bleeding tendencies, including but not limited to platelet count \<100×109/L; received heparin treatment within 48 hours with an activated partial thromboplastin time (APTT) ≥35s; recent oral anticoagulant therapy with international normalized ratio (INR) \>3; Note: Patients without a history of coagulation abnormalities or without suspicion of coagulation abnormalities do not need to wait for laboratory test results before enrollment;
7. Seizures at stroke onset or during the course, hard to accurately judge the baseline NIHSS score;
8. Female who is known to be pregnant, lactation, or tested positive for pregnancy at time of admission;
9. Currently participating in another investigational drug study or medical device treatments that may interfere with the results of this study;
10. Other conditions deemed unsuitable for participation, in the opinion of the investigator, or that may pose significant risks to the patient if participating the study.

Imaging Exclusion Criteria:

1. Evidence of intracranial hemorrhage on CT/MRI, including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/extradural hemorrhage;
2. Significant midline displacement, hernia of brain, or ventricular mass effect with midline displacement confirmed on CT/MRI;
3. Anticipated impossibility to complete endovascular treatment, such as vascular tortuosity, severe vascular wall calcification, etc.;
4. Aortic dissection;
5. Multiple intracranial large vessel occlusions confirmed by CTA or MRA, unable to clearly identify the symptomatic vessel, such as bilateral MCA occlusions or occlusions involving both the MCA and basilar artery;
6. Suspected or confirmed occluded artery is non-acute occlusion.

Primary outcomes:
measure: the rate of excellent outcome at () days
timeFrame: 90±7 days and 365±30 days
Secondary outcomes:
measure: mRS shift
timeFrame: 90±7 days and 365±30 days
measure: proportion of subjects with good neurological function prognosis
timeFrame: 90±7 days and 365±30 days
Other outcomes:
measure: the rate of symptomatic intracranial hemorrhage
timeFrame: within 48 hours
measure: rate of early neurological deterioration
timeFrame: within 7 days
measure: mortality
timeFrame: 90±7 days and 365±30 days
Locations:
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital
state: Fujian
Study officials:
affiliation: Zhangzhou Municipal Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University
name: Wenhuo Chen, MD
role: STUDY_DIRECTOR
References:
citation: Sarraj A, Albers GW, Blasco J, Arenillas JF, Ribo M, Hassan AE, de la Ossa NP, Wu TY, Cardona Portela P, Abraham MG, Chen M, Maali L, Kleinig TJ, Cordato D, Wallace AN, Schaafsma JD, Sangha N, Gibson DP, Blackburn SL, De Lera Alfonso M, Pujara D, Shaker F, McCullough-Hicks ME, Moreno Negrete JL, Renu A, Beharry J, Cappelen-Smith C, Rodriguez-Esparragoza L, Olive-Gadea M, Requena M, Almaghrabi T, Mendes Pereira V, Sitton C, Martin-Schild S, Song S, Ma H, Churilov L, Mitchell PJ, Parsons MW, Furlan A, Grotta JC, Donnan GA, Davis SM, Campbell BCV; PERFECT-MILD Collaborators. Thrombectomy versus Medical Management in Mild Strokes due to Large Vessel Occlusion: Exploratory Analysis from the EXTEND-IA Trials and a Pooled International Cohort. Ann Neurol. 2022 Sep;92(3):364-378. doi: 10.1002/ana.26418. Epub 2022 Jul 25.