Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

NCT06210633 | Recruiting DMC

• 1 other identifier: XL STROKE
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Acute Ischemic Stroke (AIS); Acute Ischemic Stroke From Large Vessel Occlusion

Keywords

Acute ischemic stroke; large vessel occlusion; endovascular thrombectomy

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale score

  The primary outcome of this study is level of disability assessed by the score on the modified Rankin Scale at 90±14 days (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; mRS 6 and 5 will be merged as the worst outcome level to avoid a shift of 6 to 5 to be seen as better outcome).

  90±14 days after enrollment

Secondary Outcomes (13)

• Independent ambulation

  90±14 days after enrollment

• Not ambulatory nor capable of body self-care

  90±14 days after enrollment

• Functional independence

  90±14 days after enrollment

• Excellent outcome

  90±14 days after enrollment

• National Institutes of Health Stroke Scale score

  5-7 days after enrollment or discharge (whichever occurred first)

Other Outcomes (6)

• Modified Rankin Scale score at 1 year

  One year after enrollment

• Not ambulatory nor capable of body self-care

  One year after enrollment

• Independent ambulation

  One year after enrollment

Study Arms (2)

Endovascular thrombectomy

Patients in this group will be treated with medical management plus endovascular thrombectomy

Other: medical management; Other: endovascular thrombectomy

Medical management

Patients in this group will be treated with guideline-based medical management alone

Other: medical management

Interventions

medical management OTHER

Medical management will be based on the recommendations of the stroke management guidelines of the Chinese Stroke Association. Patients will receive intravenous thrombolysis according to the guidelines if they are eligible for thrombolysis. Patients who are not treated with intravenous thrombolysis will be treated with aspirin, unless an indication for early anticoagulation is present.

Endovascular thrombectomy; Medical management

endovascular thrombectomy OTHER

The use of devices (i.e. stent-retriever, aspiration catheter) is at the discretion of neurointerventionalist. Intra-arterial administration of alteplase, tenecteplase, tirofiban, angioplasty and stenting will also be permitted.

Endovascular thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years;
• Presenting with acute ischemic stroke within 24 hours of time from last known well;
• The patient or patient's representative signs a written informed consent form before enrollment.
• Occlusion of internal carotid artery, or the middle cerebral artery M1 or M2 segments confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography;
• The baseline ASPECTS is 0 to 2 based on NCCT or diffusion weighted imaging, or cerebral extra-large ischemic core volume ≥85ml (defined as relative cerebral blood flow \<30% on CT perfusion or an apparent diffusion coefficient \<620×10\^-6 mm2/s on MRI).

You may not qualify if:

• CT or MRI evidence of acute intracranial hemorrhage;
• Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
• Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test;
• Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
• Any terminal illness with life expectancy less than 6 months;
• Participation in other clinical treatment trials.

Sponsors & Collaborators

• Zhongming Qiu: lead
• Xiangtan Central Hospital (The Affiliated Hospital of Hunan University): collaborator

Study Sites (1)

Xiangtan Central Hospital

Xiangtan, Hunan, 421001, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Guangxiong Yuan

  Xiangtan Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhongming Qiu

CONTACT

+8613236599269; qiuzhongmingdoctor@163.com

Thanh N. Nguyen

CONTACT

thanh.nguyen@bmc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 18, 2024
• Study Start: January 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 3 years after the trial results are revealed
• Access Criteria: After approval of a proposal from principal investigator

Locations

CN (1)