Clinical trial NCT06388148: Endovascular Treatment for eXtra-Large Ischemic Stroke
Official title: Efficacy and Safety of Endovascular Thrombectomy Plus Medical Management Versus Medical Management Alone in Acute Ischemic Stroke Patients With Large Vessel Occlusion and Extra-Large Infarct Core: A Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute Ischemic
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital, University of South China
name: Xiangtan Central Hospital
name: Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
name: Longyan First Affiliated Hospital of Fujian Medical University
name: Taizhou First People's Hospital
name: Zhangzhou Affiliated Hospital of Fujian Medical University
First posted: 2024-04-29
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Rankin Scale score
timeFrame: 90 days after randomization
Secondary outcomes:
measure: Rate of successful reperfusion
timeFrame: Within 5 minutes at the end of angiogram
measure: Rate of excellent outcome
timeFrame: 90 days after randomization
measure: Rate of functional independence
timeFrame: 90 days after randomization
measure: Rate of independent ambulation
timeFrame: 90 days after randomization
Other outcomes:
Locations:
city: Hengyang
country: China
facility: The First Affiliated Hospital, Hengyang Medical School, University of South China
state: Hunan
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
Study officials:
affiliation: Xiangtan Central Hospital
name: Guangxiong Yuan
role: PRINCIPAL_INVESTIGATOR
affiliation: Hangzhou First Hospital of Zhejiang University
name: Congguo Yin
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhangzhou Affiliated Hospital of Fujian Medical University
name: Tingyu Yi
role: PRINCIPAL_INVESTIGATOR
affiliation: Longyan First Hospital of Fujian Medical University
name: Chong Zheng
role: PRINCIPAL_INVESTIGATOR
affiliation: Taizhou First People's Hospital
name: Chenghua Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital, Hengyang Medical School, University of South China
name: Zhongfan Ruan
role: PRINCIPAL_INVESTIGATOR
References: