Endovascular treatment for stroke beyond 24 hours
EndoVascular Treatment Beyond 24 Hours for AcutE Ischemic Stroke Caused by Anterior Circulation LArge Vessel STEnosis: A Multicenter RandomizeD Controlled Trial(EVT-BELATED)
This study is testing whether a specific stroke treatment can help people who have had a stroke more than 24 hours ago feel better and regain independence compared to just receiving standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 432 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Second Hospital of Anhui Medical University Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06959199 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and efficacy of endovascular therapy (EVT) for patients with acute ischemic stroke caused by large vessel occlusion in the anterior circulation, who present beyond the standard 24-hour treatment window. It is a multicenter, prospective, randomized, open-label study where eligible participants will be assigned to either receive EVT combined with best medical management or best medical management alone. The primary goal is to assess functional independence at 90 days post-treatment, using the modified Rankin Scale to measure outcomes. The study aims to provide insights into the potential benefits of EVT in a previously underexplored timeframe for stroke treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with acute ischemic stroke due to anterior circulation large vessel occlusion, presenting between 24 to 120 hours after symptom onset.
Not a fit: Patients with strokes caused by conditions other than anterior circulation large vessel occlusion or those presenting outside the specified time window may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could expand treatment options for stroke patients presenting beyond the current 24-hour window, potentially improving outcomes.
How similar studies have performed: While EVT is established for acute strokes within 24 hours, this study explores a novel approach beyond that timeframe, which has limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hefei, Anhui
- The Second (Affiliated) Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Qi Li, professor
- Email: qili_md@126.com
- Phone: +8618623511778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.