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Search / Trial NCT06388148

Endovascular Treatment for eXtra-Large Ischemic Stroke

Launched by ZHONGMING QIU · Apr 24, 2024

Trial Information

Current as of June 12, 2025

Recruiting

Keywords

ClinConnect Summary

The XL STROKE-2 clinical trial is studying a treatment called endovascular thrombectomy, which is a procedure used to remove blood clots from the brain in patients who have experienced a large ischemic stroke. This type of stroke occurs when a blood vessel supplying blood to the brain becomes blocked, and it can lead to significant brain damage if not treated quickly. The trial aims to determine if this procedure is safe and effective for patients with a particularly large area of brain affected by the stroke.

To participate in this trial, individuals must be 18 years or older, have experienced an acute ischemic stroke within the last 6 hours, and have specific types of blood vessel blockages confirmed by imaging tests. However, people with certain conditions, like bleeding disorders or severe illness, may not be eligible. Participants will receive the thrombectomy procedure and will be monitored for their recovery. This research is important because it may help improve treatment options for patients with severe strokes, potentially leading to better outcomes.

Gender

ALL

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.

About Zhongming Qiu

Zhongming Qiu is a dedicated clinical trial sponsor specializing in the development and oversight of innovative therapeutic solutions across various medical fields. With a strong commitment to advancing healthcare, Zhongming Qiu leverages robust research methodologies and strategic partnerships to facilitate the successful execution of clinical trials. Their focus on patient safety, regulatory compliance, and high-quality data collection underscores their mission to contribute to the scientific community and enhance treatment options for patients worldwide. Through a combination of expertise and collaboration, Zhongming Qiu aims to drive progress in clinical research and improve health outcomes.

Locations

Ganzhou, Jiangxi, China

Xiangtan, Hunan, China

Hengyang, Hunan, China

Patients applied

0 patients applied

Trial Officials

Guangxiong Yuan

Principal Investigator

Xiangtan Central Hospital

Congguo Yin

Principal Investigator

Hangzhou First Hospital of Zhejiang University

Tingyu Yi

Principal Investigator

Zhangzhou Affiliated Hospital of Fujian Medical University

Chong Zheng

Principal Investigator

Longyan First Hospital of Fujian Medical University

Chenghua Xu

Principal Investigator

Taizhou First People's Hospital

Zhongfan Ruan

Principal Investigator

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported