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

Last updated: May 8, 2025
Sponsor: The Second Hospital of Anhui Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Occlusions

Stroke

Treatment

Best Medical Treatment

Endovascular Treatment

Clinical Study ID

NCT06959199
YX2024-241(F1)
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Age > 18 years

  • Acute ischemic stroke with a time window of 24 to 120 hours from symptom onset orlast known well, or progressive ischemic stroke with a time from symptom onset of 24hours to 7 days (A ≥4-point increase in NIHSS attributable to the culprit vesselterritory )

  • NIHSS score 5-25

  • Occlusion or ≥70% stenosis of the internal carotid artery or the M1/M2 segment ofthe middle cerebral artery, confirmed by CTA, MRA, or DSA, and deemed to be theculprit 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 MCAterritory, with evidence of DWI-FLAIR mismatch or MR perfusion showing a coreinfarct 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 definedascollateral filling >50% of the MCA territory (Tan score ≥2) and an ASPECTSscore ≥6);

  3. CTP-based criteria: ischemic core volume ≤30 ml, mismatch ratio ≥ 1.8, andmismatch volume ≥ 15mL

  • Signed informed consent obtained

Exclusion

Exclusion criteria:

  • Pre-stroke mRS ≥ 2

  • Patients unable to undergo vascular imaging

  • Patients with known allergies to iodine contrast agents, anesthetics, or anycontraindication to endovascular treatment

  • Prior endovascular therapy performed after the index stroke event during the currenthospitalization

  • Intracranial hemorrhage identified on initial imaging

  • Platelet count <50×10⁹/L, or presence of a known hemorrhagic diathesis , coagulationfactor deficiencies, or use of oral anticoagulation therapy with an InternationalNormalized Ratio (INR) > 3.0

  • Refractory hypertension, defined as sustained systolic blood pressure >200 mmHg ordiastolic blood pressure >120 mmHg despite optimal medical management

  • History of intracranial hemorrhage within the past 3 months, including parenchymalhemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epiduralhemorrhage, or subdural hemorrhage

  • Significant mass effect with midline shift confirmed by CT or MRI

  • Suspected cardioembolic stroke or stroke due to non-atherosclerotic etiologies, suchas:arterial dissection,Moyamoya disease, Infective endocarditis, or Immune-mediatedvasculitis

  • 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 3months

  • Deemed unsuitable for participation by the investigator for any reason

Study Design

Total Participants: 432
Treatment Group(s): 2
Primary Treatment: Best Medical Treatment
Phase:
Study Start date:
March 24, 2025
Estimated Completion Date:
December 30, 2029

Study 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).

Connect with a study center

  • The Second (Affiliated) Hospital of Anhui Medical University

    Hefei, Anhui 230031
    China

    Active - Recruiting

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