Endovascular treatment for patients with extra-large ischemic stroke

Efficacy and Safety of Endovascular Thrombectomy Plus Medical Management Versus Medical Management Alone in Acute Ischemic Stroke Patients With Large Vessel Occlusion and Extra-Large Infarct Core: A Multicenter, Randomized Controlled Trial

This study is testing if a procedure called thrombectomy can help people with very large strokes caused by blocked blood vessels feel better compared to just getting standard medical care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 286 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xinqiao Hospital of Chongqing (Academic / other)
• Locations: 2 sites (Hengyang, Hunan and 1 other locations)
• Trial ID: NCT06388148 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with acute ischemic stroke and an infarct core volume of 100 mL or more.

Not a fit: Patients with evidence of hemorrhage, significant mass effect, or severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with extra-large ischemic strokes, potentially improving their functional outcomes.

How similar studies have performed: While several studies have shown success with endovascular thrombectomy for smaller infarcts, this approach for extra-large ischemic strokes is still being explored and is considered novel.

Eligibility criteria

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 this trial is running

Hengyang, Hunan and 1 other locations

• 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

Conditions Stroke, Acute Ischemic