Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZhongming Qiu

About this trial

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.

Eligibility criteria

Qualifiers

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.

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;

Disqualifiers

CT or MRI evidence of acute intracranial hemorrhage;

Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;

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

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

Trial design

Treatments tested in this trial

  • medical management
  • endovascular thrombectomy

Treatment groups

1,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Zhongming Qiu

Lead sponsor

Xinqiao Hospital of Chongqing

Sponsor institution

Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)

Collaborator