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RecruitingNCT06388148XL STROKE-2Updated Dec 26, 2025

Endovascular Treatment for eXtra-Large Ischemic Stroke

An interventional study of Medical management and Endovascular thrombectomy in Stroke, Acute Ischemic, sponsored by Zhongming Qiu. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by Zhongming Qiu · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
286
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

Read the detailed description

Several randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, six randomized controlled trials demonstrated the efficacy and safety of endovascular 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 0 to 2) accounted for a small proportion of these trials. Therefore, the role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. That is to say, exactly where the lower limit of endovascular thrombectomy is unknown. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

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Conditions studied

  • Stroke, Acute Ischemic

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03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 286 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Zhongming Qiu is the lead sponsor of 11 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18 years or older, and modified Rankin scale score = 0 or 1 in patients 80 years or older;
  2. Acute ischemic stroke within 6 hours from last known well to randomization, or with negative MRI-FLAIR (no change on FLAIR sequence and presence of infarct on MRI-DWI) if > 6 hours or unknown last known well time;
  3. Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by CTA/MRA/DSA;
  4. Baseline ASPECTS score of 0-2 or infarct core volume ≥100ml;
  5. The patient or patient's representative signs a written informed consent form.

Exclusion criteria

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. Vessel tortuosity where it is expected that the thrombectomy device will not be able to reach the occlusion site or result in unstable access;
  4. History of bleeding disorders, severe heart, liver or kidney disease, or sepsis;
  5. Currently participating in another investigational drug study;
  6. Any terminal illness with life expectancy less than 6 months.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
286 participants (estimated)

Study arms

  • Experimental
    Endovascular thrombectomy

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

    Drug: Medical management · Procedure: Endovascular thrombectomy

  • Active comparator
    Medical management

    Patients in this group will be treated with medical management alone

    Drug: Medical management

Interventions

  • DrugMedical management

    Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.

  • ProcedureEndovascular thrombectomy

    Endovascular thrombectomy with stent-retriever, local aspiration, angioplasty, and/or stenting.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 90 days after randomization

Secondary outcomes

  1. Rate of successful reperfusion

    Final reperfusion grade of 2b-3 on eTICI scale (This 7-point compilation of TICI grades, termed the expanded TICI (eTICI), reflects all previously reported thresholds used to define reperfusion after endovascular stroke therapy. In brief, eTICI grade 0 is equivalent to no reperfusion or 0% filling of the downstream territory; eTICI 1 reflects thrombus reduction without any reperfusion of distal arteries; eTICI 2a is reperfusion in less than half or 1-49% of the territory; eTICI 2b50 is 50-66% reperfusion, exceeding the modified TICI (mTICI) 2B threshold but below the original TICI 2B cut-off point; eTICI 2b67 is 67-89% reperfusion, exceeding TICI but below TICI 2C; eTICI 2c is equivalent to TICI 2C or 90-99% reperfusion; and eTICI 3 is complete or 100% reperfusion, tantamount to TICI 3.)

    Time frame: Within 5 minutes at the end of angiogram

  2. Rate of excellent outcome

    Score of 0-1 on the modified Rankin scale

    Time frame: 90 days after randomization

  3. Rate of functional independence

    Score of 0-2 on the modified Rankin scale

    Time frame: 90 days after randomization

  4. Rate of independent ambulation

    Score of 0-3 on the modified Rankin scale

    Time frame: 90 days after randomization

07

Study locations

2 of 2 sites recruiting
  • The First Affiliated Hospital, Hengyang Medical School, University of South China
    Hengyang, Hunan, China
    Recruiting
  • Xiangtan Central Hospital
    Xiangtan, Hunan 421001, China
    Recruiting
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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Csr, Analytic code

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06388148
Lead sponsor
Zhongming Qiu
Collaborators
The First Affiliated Hospital of University of South China, Xiangtan Central Hospital, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Longyan City First Hospital, Taizhou First People's Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University
Responsible party
Zhongming Qiu (Professor, Xinqiao Hospital of Chongqing) — Sponsor-investigator
First posted
Apr 29, 2024
Start date
Jun 16, 2024
Primary completion
Oct 31, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Dec 26, 2025

Study contacts

Zhongfan Ruan
Contact
ruanzhongfan@sina.com
15616320002
Zhongming Qiu
Contact
qiuzhongmingdoctor@163.com
13236599269
Guangxiong Yuan
principal investigator · Xiangtan Central Hospital
Congguo Yin
principal investigator · Hangzhou First Hospital of Zhejiang University
Tingyu Yi
principal investigator · Zhangzhou Affiliated Hospital of Fujian Medical University
Chong Zheng
principal investigator · Longyan First Hospital of Fujian Medical University
Chenghua Xu
principal investigator · Taizhou First People's Hospital
Zhongfan Ruan
principal investigator · The First Affiliated Hospital, Hengyang Medical School, University of South China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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