NCT06959199Recruiting
Endovascular Treatment Beyond 24 Hours for Acute Ischemic Stroke Caused by Anterior Circulation Large Vessel Stenosis
EndoVascular Treatment Beyond 24 Hours for AcutE Ischemic Stroke Caused by Anterior Circulation LArge Vessel STEnosis: A Multicenter RandomizeD Controlled Trial(EVT-BELATED)
Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 432 (estimated)
- First submitted
- 26 Apr 2025
- Start date
- 24 Mar 2025
- Primary completion date
- 30 Dec 2029
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Diseases
- Stroke
- NCT number
- NCT06959199
What you commit to
- Study type: Interventional
- Planned participants: 432
- From 24 Mar 2025 to the primary completion date, 30 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior endovascular therapy performed after the index stroke event during the current hospitalization
- Prior intracranial stent placement in the same culprit vessel
- Major surgery performed within the past 30 days
Other illness
- Pre-stroke mRS ≥ 2
- Patients with known allergies to iodine contrast agents, anesthetics, or any contraindication to endovascular treatment
- Intracranial hemorrhage identified on initial imaging
- 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
- Suspected cardioembolic stroke or stroke due to non-atherosclerotic etiologies, such as:arterial dissection,Moyamoya disease, Infective endocarditis, or Immune-mediated vasculitis
Lab values
- 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
Other
- Patients unable to undergo vascular imaging
- Significant mass effect with midline shift confirmed by CT or MRI
- 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
Who the study is looking for
- 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:
- 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;
- 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);
- CTP-based criteria: ischemic core volume ≤30 ml, mismatch ratio ≥ 1.8, and mismatch volume ≥ 15mL
- Signed informed consent obtained
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital Of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.