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Endovascular Treatment for eXtra-Large Ischemic Stroke

ConditionStroke, Acute Ischemic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhongming Qiu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older, and modified Rankin scale score = 0 or 1 in patients 80 years or older;

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;

Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by CTA/MRA/DSA;

Baseline ASPECTS score of 0-2 or infarct core volume ≥100ml;

Disqualifiers

CT or MR evidence of hemorrhage;

Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;

Vessel tortuosity where it is expected that the thrombectomy device will not be able to reach the occlusion site or result in unstable access;

History of bleeding disorders, severe heart, liver or kidney disease, or sepsis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medical management

    Drug

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

  • Endovascular thrombectomy

    Procedure/Surgery

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

Treatment groups

286 Participants
are divided into 2 treatment groups
Group A: Endovascular thrombectomyExperimental treatment 2 interventions
Group B: Medical managementActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongming Qiu

Lead sponsor

Xinqiao Hospital of Chongqing

Sponsor institution

The First Affiliated Hospital of University of South China

Collaborator

Xiangtan Central Hospital

Collaborator

Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

Collaborator

Longyan First Affiliated Hospital of Fujian Medical University

Collaborator

Taizhou First People's Hospital

Collaborator

Zhangzhou Affiliated Hospital of Fujian Medical University

Collaborator

Source ClinicalTrials.gov
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