Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

Recruiting

• Conditions: Stroke, Acute
• Interventions: Other: medical management; Other: endovascular thrombectomy

• Registration Number: NCT06210633
• Lead Sponsor: Zhongming Qiu

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-07
• Study First Posted: 2024-01-18
• Study Start: 2024-01-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-03-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 990

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endovascular thrombectomy	medical management	Patients in this group will be treated with medical management plus endovascular thrombectomy
Endovascular thrombectomy	endovascular thrombectomy	Patients in this group will be treated with medical management plus endovascular thrombectomy
Medical management	medical management	Patients in this group will be treated with medical management alone

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale score	90 days after enrollment	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

Secondary Outcome Measures

Name	Time	Method
independent ambulation (defined as a mRS score of 0-3) at 90 days	90 days after enrollment	Score of 0-3 on the modified Rankin scale
Not requiring constant care or better (defined as a mRS score of 0-4) at 90 days	90 days after enrollment	Score of 0-4 on the modified Rankin scale
Functional independence	90 days after enrollment	Score of 0-2 on the modified Rankin scale
Excellent outcome	90 days after enrollment	Score of 0-1 on the modified Rankin scale
Incidence of symptomatic intracranial hemorrhage (SICH)	48 hours after enrollment	using Heidelberg criteria to assess SICH
Mortality	90 days after enrollment	Death from any cause

Trial Locations

Locations (1)

Xiangtan Central Hospital; 🇨🇳 Xiangtan, Hunan, China