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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ganzhou, Jiangxi, China
Xiangtan, Hunan, China
Hengyang, Hunan, China
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