Endovascular Treatment Beyond 24 Hours for Acute Ischemic Stroke Caused by Anterior Circulation Large Vessel Stenosis

NCT06959199 | Recruiting DMC

• 1 other identifier: YX2024-241(F1)
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebrovascular Disorders; Brain Diseases; Nervous System Diseases; Vascular Diseases; Ischemic Stroke; Infarction

Keywords

Ischemic stroke; Endovascular therapy; Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Ordinal distribution of mRS

  90 ± 7 days

• Excellent functional outcome

  90 ± 7 days

• Poor functional outcome

  90 ± 7 days

• Early neurological deterioration

  24 ± 12 hours

• Any neurological improvement

  24 ± 12 hours

Other Outcomes (2)

• Symptomatic intracranial hemorrhage

  24 ± 12 hours

• All cause mortality

  90 ± 7 days

Study Arms (2)

Endovascular Treatment plus Best Medical Treatment

EXPERIMENTAL

Patients in this group will receive endovascular therapy (EVT) plus best medical treatment.

Procedure: Endovascular Treatment; Drug: Best Medical Treatment

Best Medical Treatment

ACTIVE COMPARATOR

Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.

Drug: Best Medical Treatment

Interventions

Endovascular Treatment PROCEDURE

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.

Endovascular Treatment plus Best Medical Treatment

Best Medical Treatment DRUG

Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.

Best Medical Treatment; Endovascular Treatment plus Best Medical Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

Study Sites (1)

The Second (Affiliated) Hospital of Anhui Medical University

Hefei, Anhui, 230031, China

RECRUITING

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders; Brain Diseases; Nervous System Diseases; Vascular Diseases; Ischemic Stroke; Infarction

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Cardiovascular Diseases; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Qi Li, professor

CONTACT

+8618623511778; qili_md@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 6, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (1)