Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke (XL-STROKE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute
• Intervention / Treatment: Other: medical management; Other: endovascular thrombectomy

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Zhongming Qiu; Phone Number: +8613236599269; Email: qiuzhongmingdoctor@163.com
• Study Contact Backup: Name: Thanh N. Nguyen; Email: thanh.nguyen@bmc.org

Study Locations

• China
  • Hunan
    • Xiangtan, Hunan, China, 421001
      • Recruiting
      • Xiangtan Central Hospital
      • Contact: Guangxiong Yuan; Phone Number: 18973223018; Email: yuanguangxiong74@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endovascular thrombectomy; Patients in this group will be treated with medical management plus endovascular thrombectomy	Other: medical management; Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.; Other: endovascular thrombectomy; Endovascular thrombectomy with stent-retriever, local aspiration, angioplasty, and/or stenting.
Medical management; Patients in this group will be treated with medical management alone	Other: medical management; Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Functional independence	Score of 0-2 on the modified Rankin scale	90 days after enrollment
Excellent outcome	Score of 0-1 on the modified Rankin scale	90 days after enrollment
Incidence of symptomatic intracranial hemorrhage (SICH)	using Heidelberg criteria to assess SICH	48 hours after enrollment
Mortality	Death from any cause	90 days after enrollment

Collaborators and Investigators

• Sponsor: Zhongming Qiu
• Collaborators: Xiangtan Central Hospital
• Investigators: Principal Investigator: Guangxiong Yuan, Xiangtan Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 7, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: XL STROKE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol, Clinical Study Report, and Analytic Code will be shared after approval of a proposal from principal investigator 3 years after the trial results are revealed.
• IPD Sharing Time Frame: 3 years after the trial results are revealed
• IPD Sharing Access Criteria: after approval of a proposal from principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No