Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

Zhongming Qiu1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Acute Ischemic Stroke (AIS)Acute Ischemic Stroke From Large Vessel Occlusion

Interventions

Medical management will be based on the recommendations of the stroke management guidelines of the Chinese Stroke Association. Patients will receive intravenous thrombolysis according to the guidelines if they are eligible for thrombolysis. Patients who are not treated with intravenous thrombolysis will be treated with aspirin, unless an indication for early anticoagulation is present.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Modified Rankin Scale score

The primary outcome of this study is level of disability assessed by the score on the modified Rankin Scale at 90±14 days (scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death; mRS 6 and 5 will be merged as the worst outcome level to avoid a shift of 6 to 5 to be seen as better outcome).

Time frame: 90±14 days after enrollment

Secondary Outcomes

Independent ambulation

Score of 0-3 on the modified Rankin scale

Time frame: 90±14 days after enrollment

Not ambulatory nor capable of body self-care

Score of 0-4 on the modified Rankin scale

Time frame: 90±14 days after enrollment

Functional independence

Score of 0-2 on the modified Rankin scale

Time frame: 90±14 days after enrollment

Excellent outcome

Score of 0-1 on the modified Rankin scale

Time frame: 90±14 days after enrollment

National Institutes of Health Stroke Scale score

Scores on the National Institutes of Health Stroke Scale range from 0 to 42, with higher scores indicating worse neurologic deficits.

Time frame: 5-7 days after enrollment or discharge (whichever occurred first)

Health-related quality of life

Health-related quality of life \[European Quality Five-Dimension Five-Level (EQ-5D-5L) scale score\]

Time frame: 90±14 days after enrollment

Incidence of symptomatic intracranial hemorrhage

Use Heidelberg criteria to assess symptomatic intracranial hemorrhage.

Time frame: 48 hours after enrollment

Incidence of any intracranial hemorrhage

Any intracranial hemorrhage within 48 hours

Time frame: 48 hours after enrollment

Incidence of decompressive hemicraniectomy

Decompressive hemicraniectomy during hospitalization

Time frame: 7 days after enrollment

Mortality during hospitalization

Death from any cause

Time frame: 7 days after enrollment

Mortality

Death from any cause

Time frame: 90±14 days after enrollment

The occurrence of non-hemorrhagic serious adverse events

The occurrence of non-hemorrhagic serious adverse events, such as pneumonia, respiratory failure, circulatory failure, cerebral herniation, acute coronary syndrome, venous thrombosis.

Time frame: through study completion, an average of 90 days

Mortality within 1 year

Death from any cause

Time frame: One year after enrollment

Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts