Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

Stroke, Acute Clinical Trial

— XL-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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06210633
• Other study ID #: XL STROKE
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Acute

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