Clinical trial NCT06210633: Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke
Official title: 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, Prospective Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
Collaborators: name: Xiangtan Central Hospital
First posted: 2024-01-18
Enrollment: 990
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients are presented with acute extra-large stroke and large vessel occlusion within 24 hours of time from last known well.

Brief summary: 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 (volume greater than 100 mL, 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: Inclusion Criteria:

Clinical inclusion criteria:

1. Acute ischemic stroke within 24 hours from onset to enrollment;
2. The patient or patient's representative signs a written informed consent form;

   Imaging inclusion criteria:
3. If the occlusion site is located in the anterior circulation, internal carotid artery, or the middle cerebral artery M1 or M2, or the anterior cerebral artery A1, the baseline ASPECTS is 0 to 2 based on NCCT, or cerebral infarction core volume ≥85ml based on CT perfusion.
4. If the occlusion site is located in the vertebrobasilar artery, then the baseline pc-ASPECTS is 0 to 5.

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. Currently pregnancy;
4. Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
5. Any terminal illness with life expectancy less than 6 months.

Primary outcomes:
measure: Modified Rankin Scale score
timeFrame: 90 days after enrollment
Secondary outcomes:
measure: independent ambulation (defined as a mRS score of 0-3) at 90 days
timeFrame: 90 days after enrollment
measure: Not requiring constant care or better (defined as a mRS score of 0-4) at 90 days
timeFrame: 90 days after enrollment
measure: Functional independence
timeFrame: 90 days after enrollment
measure: Excellent outcome
timeFrame: 90 days after enrollment
measure: Incidence of symptomatic intracranial hemorrhage (SICH)
timeFrame: 48 hours after enrollment
measure: Mortality
timeFrame: 90 days after enrollment
Other outcomes:
Locations:
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
Study officials:
affiliation: Xiangtan Central Hospital
name: Guangxiong Yuan
role: PRINCIPAL_INVESTIGATOR
References: