StrokeCerebrovascular DisordersBrain DiseasesNervous System DiseasesVascular DiseasesIschemic StrokeInfarction
Investigational drug(s) / intervention(s)
Endovascular TreatmentBest Medical Treatment
Endovascular Treatment: EVT procedures may include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, or stenting, or other intra-arterial procedures as deemed appropriate by the treating physician.
Best Medical Treatment: Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.
Study summary
Endovascular therapy (EVT) is currently recommended as the first-line treatment for patients with acute large vessel occlusion (LVO) in the anterior circulation within 24 hours of symptom onset. However, the therapeutic benefit of EVT beyond 24-hour window remains uncertain due to limited evidence. The EVT-BELATED trial is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study designed to assess the safety and efficacy of EVT in patients with acute ischemic stroke (AIS) caused by anterior circulation LVO presenting beyond 24 hours after symptom onset.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria:
* Age \> 18 years
* Acute ischemic stroke with a time window of 24 to 120 hours from symptom onset or last known well, or progressive ischemic stroke with a time from symptom onset of 24 hours to 7 days (A ≥4-point increase in NIHSS attributable to the culprit vessel territory )
* NIHSS score 5-25
* Occlusion or ≥70% stenosis of the internal carotid artery or the M1/M2 segment of the middle cerebral artery, confirmed by CTA, MRA, or DSA, and deemed to be the culprit vessel responsible for the clinical presentation of acute ischemic stroke
* Meet one of the following imaging criteria:
1. MRI-based criteria: the infarct volume on DWI is less than one-third of the MCA territory, with evidence of DWI-FLAIR mismatch or MR perfusion showing a core infarct volume ≤30 ml, a mismatch ratio ≥1.8, and a mismatch volume ≥15 ml;
2. CTA-based criteria: good collateral circulation on the affected side defined ascollateral filling \>50% of the MCA territory (Tan score ≥2) and an ASPECTS score ≥6);
3. CTP-based criteria: ischemic core volume ≤30 ml, mismatch ratio ≥ 1.8, and mismatch volume ≥ 15mL
* Signed informed consent obtained
Exclusion criteria:
* Pre-stroke mRS ≥ 2
* Patients unable to undergo vascular imaging
* Patients with known allergies to iodine contrast agents, anesthetics, or any contraindication to endovascular treatment
* Prior endovascular therapy performed after the index stroke event during the current hospitalization
* Intracranial hemorrhage identified on initial imaging
* Platelet count \<50×10⁹/L, or presence of a known hemorrhagic diathesis , coagulation factor deficiencies, or use of oral anticoagulation therapy with an International Normalized Ratio (INR) \> 3.0
* Refractory hypertension, defined as sustained systolic blood pressure \>200 mmHg or diastolic blood pressure \>120 mmHg despite optimal medical management
* History of intracranial hemorrhage within the past 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage, or subdural hemorrhage
* Significant mass effect with midline shift confirmed by CT or MRI
* Suspected cardioembolic stroke or stroke due to non-atherosclerotic etiologies, such as:arterial dissection,Moyamoya disease, Infective endocarditis, or Immune-mediated vasculitis
* Prior intracranial stent placement in the same culprit vessel
* Major surgery performed within the past 30 days
* Pregnant or current breastfeeding
* Presence of severe systemic comorbidities with a life expectancy of less than 3 months
* Deemed unsuitable for participation by the investigator for any reason
Primary outcome measure(s)
Functional independence — 90 ± 7 days The proportion of patients achieving functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 at 90 ± 7 days.
The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
Trial sites (1)
Facility
City
Region
Status
The Second (Affiliated) Hospital of Anhui Medical University
Hefei
Anhui
Recruiting
More The Second Hospital of Anhui Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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