Stroke, Acute Ischemic
Conditions
Brief 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.
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.
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.
Sponsors
The First Affiliated Hospital, University of South China
Xiangtan Central Hospital
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Longyan First Affiliated Hospital of Fujian Medical University
Taizhou First People's Hospital
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhongming Qiu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale score | 90 days after randomization | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful reperfusion | Within 5 minutes at the end of angiogram | 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.) |
| Rate of excellent outcome | 90 days after randomization | Score of 0-1 on the modified Rankin scale |
| Rate of functional independence | 90 days after randomization | Score of 0-2 on the modified Rankin scale |
| Rate of independent ambulation | 90 days after randomization | Score of 0-3 on the modified Rankin scale |
Countries
China
Contacts
Primary ContactZhongfan Ruan
Backup ContactZhongming Qiu
Outcome results
None listed