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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06210633
Other study ID # XL STROKE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 20, 2024
Est. completion date September 30, 2025

Study information

Verified date April 2024
Source Xinqiao Hospital of Chongqing
Contact Zhongming Qiu
Phone +8613236599269
Email qiuzhongmingdoctor@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date September 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
medical management
Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.
endovascular thrombectomy
Endovascular thrombectomy with stent-retriever, local aspiration, angioplasty, and/or stenting.

Locations

Country Name City State
China Xiangtan Central Hospital Xiangtan Hunan

Sponsors (2)

Lead Sponsor Collaborator
Zhongming Qiu Xiangtan Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Rankin Scale score Modified Rankin scale score (mRS): 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 90 days after enrollment
Secondary independent ambulation (defined as a mRS score of 0-3) at 90 days Score of 0-3 on the modified Rankin scale 90 days after enrollment
Secondary Functional independence Score of 0-2 on the modified Rankin scale 90 days after enrollment
Secondary Excellent outcome Score of 0-1 on the modified Rankin scale 90 days after enrollment
Secondary Incidence of symptomatic intracranial hemorrhage (SICH) using Heidelberg criteria to assess SICH 48 hours after enrollment
Secondary Mortality Death from any cause 90 days after enrollment
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