Brain Diseases, Cerebrovascular Disorders, Infarction, Ischemic Stroke, Nervous System Diseases, Stroke, Vascular Diseases
Conditions
Keywords
Ischemic stroke, Endovascular therapy, Stroke
Brief 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.
Detailed description
This study is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) trial. Eligible participants will be adults (age \>18 years) presenting with acute ischemic stroke (AIS) due to anterior circulation large vessel occlusion (LVO), either 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. Participants who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 1:1 ratio to one of two treatment arms. The control group will receive best medical management alone, while the intervention group will receive best medical management in combination with endovascular therapy (EVT). EVT procedures may include mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty, or stenting, as deemed appropriate by the treating physician. The primary objective of the study is to evaluate the safety and efficacy of EVT in patients presenting with AIS due to anterior circulation LVO beyond 24 hours from symptom onset. The primary endpoint is functional independence at 90 days, defined as a score of 0-2 on the modified Rankin Scale (mRS).
Interventions
PROCEDUREEndovascular 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.
DRUGBest Medical Treatment
Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.
Sponsors
The Second Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ordinal distribution of mRS | 90 ± 7 days | Ordinal distribution of the modified Rankin Scale (mRS) 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. |
| Excellent functional outcome | 90 ± 7 days | Number of participants achieving an excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0-1 at 90 ± 7 days follow-up. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes. |
| Poor functional outcome | 90 ± 7 days | Number of participants achieving a poor functional outcome, defined as a modified Rankin Scale (mRS) score of 4-6 at 90 ± 7 days follow-up. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes. |
| Early neurological deterioration | 24 ± 12 hours | The proportion of patients with an increase of ≥ 4 points in the National Institutes of Health Stroke Scale (NIHSS) score, within 24 ± 12 hours post-randomization. The NIHSS is a standardized 11-item assessment tool designed to quantify neurological deficits in patients with acute stroke. The total score ranges from 0 to 42, with higher values indicating more severe deficits. |
| Any new ischemic stroke events | 3 months | Any new ischemic stroke events within 3 months |
| Any ischemic stroke event or revascularization | 3-12 months | Any ischemic stroke event or revascularization of the culprit vessel between 3 and 12 months post-randomization. |
| Any neurological improvement | 24 ± 12 hours | The proportion of patients with a reduction of ≥ 2 points in the National Institutes of Health Stroke Scale (NIHSS) score from baseline at 24 ± 12 hours post-randomization. The NIHSS is a standardized 11-item assessment tool designed to quantify neurological deficits in patients with acute stroke. The total score ranges from 0 to 42, with higher values indicating more severe deficits. |
| Early neurological improvement | 24 ± 12 hours | The proportion of patients with a reduction of ≥ 4 points in the National Institutes of Health Stroke Scale (NIHSS) score from baseline at 24 ± 12 hours post-randomization. The NIHSS is a standardized 11-item assessment tool designed to quantify neurological deficits in patients with acute stroke. The total score ranges from 0 to 42, with higher values indicating more severe deficits. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic intracranial hemorrhage | 24 ± 12 hours | The incidence of symptomatic intracranial hemorrhage within 24 ± 12 hours post-randomization. |
| All cause mortality | 90 ± 7 days | All cause mortality at 90 ± 7 days. |
Countries
China
Contacts
Primary ContactQi Li, professor
Outcome results
None listed