Status:
RECRUITING
Endovascular Treatment Beyond 24 Hours for Acute Ischemic Stroke Caused by Anterior Circulation Large Vessel Stenosis
Lead Sponsor:
The Second Hospital of Anhui Medical University
Conditions:
Stroke
Cerebrovascular Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
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. Howev...
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...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
Exclusion
Key Trial Info
Start Date :
March 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2029
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT06959199
Start Date
March 24 2025
End Date
December 30 2029
Last Update
May 14 2025
Active Locations (1)
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1
The Second (Affiliated) Hospital of Anhui Medical University
Hefei, Anhui, China, 230031