NCT06388148Recruiting
Endovascular Treatment for eXtra-Large Ischemic Stroke
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
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 286 (estimated)
- First submitted
- 21 Apr 2024
- Start date
- Jun 2024
- Primary completion date
- Oct 2026
- Lead sponsor
- Zhongming Qiu
- Diseases
- Stroke
- NCT number
- NCT06388148
What you commit to
- Study type: Interventional
- Planned participants: 286
- From Jun 2024 to the primary completion date, Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in another investigational drug study;
Other illness
- CT or MR evidence of hemorrhage;
- History of bleeding disorders, severe heart, liver or kidney disease, or sepsis;
- Any terminal illness with life expectancy less than 6 months.
Other
- 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;
Who the study is looking for
- 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;
- The patient or patient's representative signs a written informed consent form.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, Hengyang Medical School, University of South China Coordinator of this site? Confirm its status | Hengyang | China | Recruiting |
| Xiangtan Central Hospital Coordinator of this site? Confirm its status | Xiangtan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.