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Search / Trial NCT07115511

Combined Recanalization Therapy for Acute Large Vessel Occlusion Stroke

Launched by TIANJIN HUANHU HOSPITAL · Aug 4, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people who have had a serious type of stroke called an acute large vessel occlusion stroke, where a large blood vessel in the brain is blocked. Sometimes, the usual treatments to open the blocked vessel don’t work. This study is testing a combined surgery that includes removing the blockage and creating a new pathway for blood flow to help restore circulation to the brain. The main goal is to see how many patients recover well, with little or no disability, three months after the surgery.

People who may be eligible for this trial are adults between 18 and 75 years old who have had this kind of stroke and for whom standard treatments to clear the blockage haven’t been successful. Participants should have been able to live independently before their stroke and meet certain brain imaging criteria showing the area affected by the stroke. If chosen for the study, patients will receive this combined surgery within 24 hours of stroke symptoms starting. The trial will carefully check how safe and effective this surgery is in helping patients recover. Certain health conditions, like serious heart problems, bleeding disorders, or other medical issues, may exclude someone from joining the study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age: 18-75.
  • 2. According to the current guidelines, there is a MT indication.
  • 3. Before stroke, mRS ≤2;
  • 4. ASPECTS ≥6;
  • 5. MCA occlusion, with or without ICA occlusion;
  • 6. MT unsuccessful, TICI score 0-1;
  • 7. Time from onset to craniotomy expected to be 24 hours or less;
  • 8. Post-awakening stroke with mismatch between the infarct zone and the penumbra zone;
  • Exclusion Criteria:
  • 1. Comorbid hemorrhagic vascular disease such as intracranial aneurysm or vascular malformation or other planned cerebrovascular surgery that may alter cerebral hemodynamics or lead to stroke;
  • 2. unstable angina or myocardial infarction, congestive heart failure within the previous 6 months;
  • 3. Pregnancy or perinatal period;
  • 4. Hematologic disorders resulting in coagulation disorders;
  • 5. Combination of other diseases with a life expectancy of less than 2 years; and
  • 6. previous treatment with intracranial or extracranial vascular bypass surgery;
  • 7. allergy to iodine or X-ray contrast media, creatinine \>3.0 mg/dl or other contraindications to arteriography;
  • 8. Uncontrolled diabetes mellitus, fasting blood sugar (FBS) \>16.7 mmol/L;
  • 9. Uncontrolled hypertension with sitting systolic blood pressure \>180 mmHg or sitting diastolic blood pressure \>110 mmHg;
  • 10. Severe hepatic dysfunction, defined as serum alanine aminotransferase (ALT) and/or alanine aminotransferase (AST) \>3 times the upper limit of normal;
  • 11. Platelets \<100×109 /L.
  • 12. Received a clinical trial drug or device within 30 days prior to screening, or is participating in another clinical trial;
  • 13. contraindication to general anesthesia or craniotomy;
  • 14. other diseases or medical history that, in the investigator's judgment, may affect the efficacy or safety evaluation of this study.

About Tianjin Huanhu Hospital

Tianjin Huanhu Hospital is a leading medical institution in Tianjin, China, dedicated to providing high-quality healthcare services and advancing medical research. As a clinical trial sponsor, the hospital is committed to fostering innovation in medical treatments and therapies through rigorous scientific investigation. With a multidisciplinary team of experienced healthcare professionals and researchers, Tianjin Huanhu Hospital adheres to the highest ethical standards and regulatory guidelines to ensure patient safety and data integrity. The hospital’s state-of-the-art facilities and collaborative approach facilitate the successful execution of clinical trials, contributing to the global advancement of medical science.

Locations

Tianjin, Tianjin, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported