Endovascular Treatment Beyond 24 Hours for Acute Ischemic Stroke Caused by Anterior Circulation Large Vessel Stenosis (EVT-BELATED)

EndoVascular Treatment Beyond 24 Hours for AcutE Ischemic Stroke Caused by Anterior Circulation LArge Vessel STEnosis: A Multicenter RandomizeD Controlled Trial(EVT-BELATED)

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.

Study Overview

• Status: Recruiting
• Conditions: Infarction; Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Nervous System Diseases; Ischemic Stroke
• Intervention / Treatment: Procedure: Endovascular Treatment; Drug: Best Medical Treatment

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).

• Study Type: Interventional
• Enrollment (Estimated): 432
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qi Li, professor; Phone Number: +8618623511778; Email: qili_md@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230031
      • Recruiting
      • The Second (Affiliated) Hospital of Anhui Medical University
      • Contact: Qi Li, professor; Phone Number: +86 18623511778; Email: qili_md@126.com
      • Principal Investigator: Qi Li, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endovascular Treatment plus Best Medical Treatment; Patients in this group will receive endovascular therapy (EVT) plus best medical treatment.	Procedure: 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.; Drug: Best Medical Treatment; Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.
Active Comparator: Best Medical Treatment; Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.	Drug: Best Medical Treatment; Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional independence	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.	90 ± 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any new ischemic stroke events	Any new ischemic stroke events within 3 months	3 months
Any ischemic stroke event or revascularization	Any ischemic stroke event or revascularization of the culprit vessel between 3 and 12 months post-randomization.	3-12 months
Ordinal distribution of mRS	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.	90 ± 7 days
Excellent functional outcome	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.	90 ± 7 days
Poor functional outcome	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.	90 ± 7 days
Early neurological deterioration	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.	24 ± 12 hours
Any neurological improvement	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.	24 ± 12 hours
Early neurological improvement	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.	24 ± 12 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic intracranial hemorrhage	The incidence of symptomatic intracranial hemorrhage within 24 ± 12 hours post-randomization.	24 ± 12 hours
All cause mortality	All cause mortality at 90 ± 7 days.	90 ± 7 days

Collaborators and Investigators

• Sponsor: The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: April 26, 2025
• First Submitted That Met QC Criteria: April 26, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Ischemic stroke; Endovascular therapy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia; Vascular Diseases; Brain Diseases; Nervous System Diseases; Cerebrovascular Disorders; Infarction
• Other Study ID Numbers: YX2024-241(F1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No