- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06179017
Endovaskulär behandling för mild stroke med akut främre cirkulation Stora kärlocklusion
Endovaskulär behandling för mild stroke med akut främre cirkulation Stort kärl ocklusion: ett multicenter randomiserat kontrollerat spår
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
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350001
- Fujian Medical University Union Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria
- Age 18-80 years old;
- Symptoms onset or last known well to randomization is within 24 hours.
- 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) ;
- Baseline NIHSS score <6 before randomization (including cases with NIHSS ≥6 at onset but improves before randomization);
- 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;
- The patient or their legal representatives voluntarilysigned the informed consent form.
Clinical Exclusion Criteria
- Premorbid Rankin Scale (mRS) score ≥ 1;
- Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure;
- 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);
- Poorly controlled hypertension (systolic blood pressure >220 mmHg or diastolic blood pressure >120 mmHg);
- Baseline blood glucose <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L);
- 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;
- Seizures at stroke onset or during the course, hard to accurately judge the baseline NIHSS score;
- Female who is known to be pregnant, lactation, or tested positive for pregnancy at time of admission;
- Currently participating in another investigational drug study or medical device treatments that may interfere with the results of this study;
- 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:
- Evidence of intracranial hemorrhage on CT/MRI, including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/extradural hemorrhage;
- Significant midline displacement, hernia of brain, or ventricular mass effect with midline displacement confirmed on CT/MRI;
- Anticipated impossibility to complete endovascular treatment, such as vascular tortuosity, severe vascular wall calcification, etc.;
- Aortic dissection;
- 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;
- Suspected or confirmed occluded artery is non-acute occlusion.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention Group:Endovascular treatment
Interventionist choose the optimal EVT strategy and device based on the patient's condition and local guidelines. This may include, but not limited to, stent-retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation and so on. The EVT regimen and relevant time points will be accurately recorded. The patient will receive the best medical treatment according to the local guidelines. |
Intervention Group:Interventionist choose the optimal endovascular treatment (EVT) strategy and device based on the patient's condition and local guidelines. The patient will receive the best medical treatment according to the local guidelines. |
|
Placebo-jämförare: Control group: Best medical treatment
Patients will receive the best medical treatment according to local guidelines, including antiplatelet agents, anticoagulants, thrombolysis, etc., but not any EVT. In the control arm, rescue EVT is allowed in patients with disease progression leading to an increase in NIHSS≥4 and excluding the impact of non-stroke factors, and the onset-to-treatment time is within 24 hours.This may include, but not limited to, stent-retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation and so on. |
Best medical treatment:Patients will receive the best medical treatment according to local guidelines, including antiplatelet agents, anticoagulants, thrombolysis, etc., but not any EVT. In the control arm, rescue EVT is allowed in patients with disease progression leading to an increase in NIHSS≥4 and excluding the impact of non-stroke factors, and the onset-to-treatment time is within 24 hours. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
the rate of excellent outcome at () days
Tidsram: 90±7 days
|
mRS score 0-1 |
90±7 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
mRS shift
Tidsram: 90±7 days
|
distribution of mRS scores |
90±7 days
|
|
proportion of subjects with good neurological function prognosis
Tidsram: 90±7 days
|
mRS score 0-2 |
90±7 days
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
the rate of symptomatic intracranial hemorrhage
Tidsram: within 48 hours
|
according to the Heidelberg criteria |
within 48 hours
|
|
rate of early neurological deterioration
Tidsram: within 7 days
|
an increase in NIHSS≥4 or an increase of ≥2 in any individual item |
within 7 days
|
|
mortality
Tidsram: 90±7 days
|
death |
90±7 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Wenhuo Chen, MD, Fujian Medical University Union Hospital
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- Wu M, Yi T, Xing P, Wu YM, Lin DL, Lin X, Huang MZ, Ren Z, Liu J, Yang P, Zheng T, Zhang M, Wang H, Chen W. Endovascular treatment for MILD ischaemic stroke with acute anterior circulation large vessel occlusion: a multicentre, prospective, randomised, clinical trial (MILD-MT) protocol. Stroke Vasc Neurol. 2026 Apr 13:svn-2025-004832. doi: 10.1136/svn-2025-004832. Online ahead of print.
- Liu J, Yi T, Xing P, Wu M, Zhang L, Zheng T, Huang M, Wu Y, Wang H, Zeng G, Li J, Peng Y, Zhu Y, Fang Y, Cai X, Luo J, Lei Y, Qin H, Fang P, Tang Y, Yuan G, Wang E, He X, Lu X, Li Z, Lei B, Cao H, Yang X, Xu C, Shang M, Anderson CS, Ren Z, Yang P, Chen W; MILD-MT Investigators. Trial of Endovascular Therapy for Mild Stroke with Large-Vessel Occlusion. N Engl J Med. 2026 Oct 23. doi: 10.1056/NEJMoa2609149. Online ahead of print.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MILD-MT
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