Endovascular treatment for patients with extra-large ischemic stroke

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 efficacy and safety of mechanical thrombectomy in patients suffering from acute extra-large ischemic strokes with large vessel occlusion. It aims to clarify the role of endovascular thrombectomy for patients with an infarct core volume greater than 100 mL, as previous studies have primarily focused on smaller infarct sizes. Participants will be randomized to receive either medical management or the thrombectomy procedure within a specified time frame after stroke onset. The study will assess functional outcomes and safety measures to determine the viability of this treatment approach for a previously underrepresented patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older, and modified Rankin scale score = 0 or 1 in patients 80 years or older;
2. Acute ischemic stroke within 6 hours from last known well to randomization, or with negative MRI-FLAIR (no change on FLAIR sequence and presence of infarct on MRI-DWI) if \> 6 hours or unknown last known well time;
3. Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by CTA/MRA/DSA;
4. Baseline ASPECTS score of 0-2 or infarct core volume ≥100ml;
5. The patient or patient's representative signs a written informed consent form.

Exclusion Criteria:

1. CT or MR evidence of hemorrhage;
2. Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
3. Vessel tortuosity where it is expected that the thrombectomy device will not be able to reach the occlusion site or result in unstable access;
4. History of bleeding disorders, severe heart, liver or kidney disease, or sepsis;
5. Currently participating in another investigational drug study;
6. Any terminal illness with life expectancy less than 6 months.

Where it's running

• The First Affiliated Hospital, Hengyang Medical School, University of South China
  Hengyang, Hunan, China Recruiting
• Xiangtan Central Hospital
  Xiangtan, Hunan, China Recruiting

Study contacts

• Principal investigator: Guangxiong Yuan — Xiangtan Central Hospital
• Study coordinator: Zhongfan Ruan
• Email: ruanzhongfan@sina.com
• Phone: 15616320002

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

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• Intra-arterial alteplase after successful reperfusion for anterior circulation ischemic 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.