Endovascular Treatment for eXtra-Large Ischemic Stroke

Zhongming Qiu286 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

286

Conditions

Stroke, Acute Ischemic

Interventions

Medical managementDRUG

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

Endovascular thrombectomyPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

The First Affiliated Hospital, Hengyang Medical School, University of South China

Hengyang, Hunan, China

RECRUITING

Xiangtan Central Hospital

Xiangtan, Hunan, China

RECRUITING

Outcomes

Primary Outcomes

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

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

Rate of excellent outcome

Score of 0-1 on the modified Rankin scale

Time frame: 90 days after randomization

Rate of functional independence

Score of 0-2 on the modified Rankin scale

Time frame: 90 days after randomization

Rate of independent ambulation

Score of 0-3 on the modified Rankin scale

Time frame: 90 days after randomization