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NCT06210633Recruiting

Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

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

Source: ClinicalTrials.gov · Last updated 31 Dec 2025

Brief summary (registry, in English)

Since 2015, many randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, five randomized controlled trials (ANGEL-ASPECT \[Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core\], LASTE \[LArge Stroke Therapy Evaluation\], RESCUE-Japan LIMIT \[The Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial\], SELECT 2 \[Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke\], and TENSION \[The Efficacy and Safety of Thrombectomy in Stroke with extended lesion and extended time window\]) demonstrated the efficacy and safety of thrombectomy for large infarct patients (defined as Alberta Stroke Program Early Computed Tomography Score \[ASPECTS\] ≥3 or infarct core \<100ml). Patients with extra-large infarct core (ASPECTS score of 2 or less) were excluded from these trials. Therefore, the efficacy of endovascular thrombectomy in patients with extra-large ischemic burden has not been well studied. The XL STROKE registry is aiming to investigate the clinical outcomes and safety of mechanical thrombectomy in acute extra-large ischemic stroke.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
5 Jan 2024
Start date
20 Jan 2024
Primary completion date
31 Dec 2025
Lead sponsor
Zhongming Qiu
Diseases
Stroke
NCT number
NCT06210633

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 20 Jan 2024 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;

Other illness

  • CT or MRI evidence of acute intracranial hemorrhage;
  • Any terminal illness with life expectancy less than 6 months;

Lab values

  • Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test;

Other

  • Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
  • Participation in other clinical treatment trials.

Who the study is looking for

  • Clinical inclusion criteria
  • Age ≥18 years;
  • Presenting with acute ischemic stroke within 24 hours of time from last known well;
  • The patient or patient's representative signs a written informed consent form before enrollment.
    • Neuroimaging inclusion criteria
  • 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;
  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xiangtan Central Hospital
Coordinator of this site? Confirm its status
XiangtanChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.