Endovascular Treatment for eXtra-Large Ischemic Stroke

Not Applicable

Recruiting

• Conditions: Stroke, Acute Ischemic
• Interventions: Drug: Medical management; Procedure: Endovascular thrombectomy

• Registration Number: NCT06388148
• Lead Sponsor: Zhongming Qiu

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.

Study Timeline

• Study First Submitted: 2024-04-21
• Study First Submitted QC: 2024-04-24
• Study First Posted: 2024-04-29
• Study Start: 2024-06-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Primary Completion: 2026-10-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 286

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endovascular thrombectomy	Medical management	Patients in this group will be treated with medical management plus endovascular thrombectomy
Endovascular thrombectomy	Endovascular thrombectomy	Patients in this group will be treated with medical management plus endovascular thrombectomy
Medical management	Medical management	Patients in this group will be treated with medical management alone

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 independent ambulation	90 days after randomization	Score of 0-3 on the modified Rankin scale
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

Trial Locations

Locations (2)

The First Affiliated Hospital, Hengyang Medical School, University of South China; 🇨🇳 Hengyang, Hunan, China

Xiangtan Central Hospital; 🇨🇳 Xiangtan, Hunan, China