Registry for Endovascular Thrombectomy in Extra-Large Stroke Patients

XL STROKE: A Nationwide Prospective Registry of Endovascular Thrombectomy for Extra-large Ischemic Stroke With Large Vessel Occlusion

This study is trying to see how well a procedure called endovascular thrombectomy works for people with very large strokes to help improve their outcomes.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xinqiao Hospital of Chongqing (Academic / other)
• Locations: 1 site (Xiangtan, Hunan)
• Trial ID: NCT06210633 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect data on the outcomes of endovascular thrombectomy in patients suffering from acute ischemic stroke with extra-large infarct cores, defined as having a volume greater than 100ml. It builds on previous randomized trials that have demonstrated the efficacy of thrombectomy in patients with large vessel occlusion. The study will enroll patients within 24 hours of stroke onset and will assess their eligibility based on specific imaging criteria. The goal is to better understand the safety and effectiveness of this intervention in a population that has been underrepresented in prior studies.

Who should consider this trial

Good fit: Ideal candidates for this study are patients who have experienced an acute ischemic stroke within the last 24 hours and have specific imaging results indicating an extra-large infarct core.

Not a fit: Patients with evidence of hemorrhage, severe comorbid conditions, or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the treatment of patients with extra-large ischemic strokes, potentially improving their functional outcomes.

How similar studies have performed: Previous studies have shown success with endovascular thrombectomy in large infarct patients, but this specific focus on extra-large infarct cores is relatively novel.

Eligibility criteria

Inclusion Criteria:

Clinical inclusion criteria

1. Age ≥18 years;
2. Presenting with acute ischemic stroke within 24 hours of time from last known well;
3. The patient or patient's representative signs a written informed consent form before enrollment.

Neuroimaging inclusion criteria

1. Occlusion of internal carotid artery, or the middle cerebral artery M1 or M2 segments confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography;
2. The baseline ASPECTS is 0 to 2 based on NCCT or diffusion weighted imaging, or cerebral extra-large ischemic core volume ≥85ml (defined as relative cerebral blood flow \<30% on CT perfusion or an apparent diffusion coefficient \<620×10\^-6 mm2/s on MRI).

Exclusion criteria

1. CT or MRI evidence of acute intracranial hemorrhage;
2. Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
3. Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test;
4. Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
5. Any terminal illness with life expectancy less than 6 months;
6. Participation in other clinical treatment trials.

Where this trial is running

Xiangtan, Hunan

• Xiangtan Central Hospital — Xiangtan, Hunan, China (Recruiting)

Study contacts

• Principal investigator: Guangxiong Yuan — Xiangtan Central Hospital
• Study coordinator: Zhongming Qiu

Conditions Acute Ischemic Stroke; Acute Ischemic Stroke From Large Vessel Occlusion; Acute ischemic stroke; large vessel occlusion; endovascular thrombectomy