Endovascular treatment for stroke beyond 24 hours

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the safety and efficacy of endovascular therapy (EVT) for patients with acute ischemic stroke caused by large vessel occlusion in the anterior circulation, who present beyond the standard 24-hour treatment window. It is a multicenter, prospective, randomized, open-label study where eligible participants will be assigned to either receive EVT combined with best medical management or best medical management alone. The primary goal is to assess functional independence at 90 days post-treatment, using the modified Rankin Scale to measure outcomes. The study aims to provide insights into the potential benefits of EVT in a previously underexplored timeframe for stroke treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• The Second (Affiliated) Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Qi Li, professor
• Email: qili_md@126.com
• Phone: +8618623511778

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Video call assessment for suspected stroke

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.