NCT07115511 Combined Recanalization Therapy for Acute Large Vessel Occlusion Stroke
| NCT ID | NCT07115511 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tianjin Huanhu Hospital |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2024-12-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this clinical trial is to evaluate the efficacy and safety of combined recanalization therapy in patients who cannot be recanalized by acute large vessel occlusive stroke. The main questions it aims to answer are: 1、Proportion of subjects with mRs score of 0-1 at 90 days after surgery Participants will: 1、In acute large vessel occlusive stroke, if traditional means cannot be recanalized, combined recanalization surgery (including arteriotomy and thrombectomy, cerebrovascular bypass surgery) is performed.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07115511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07115511 currently recruiting?
Yes, NCT07115511 is actively recruiting participants. Contact the research team at sunnygao_sg@163.com for enrollment information.
Where is the NCT07115511 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07115511 clinical trial?
NCT07115511 is sponsored by Tianjin Huanhu Hospital. The trial plans to enroll 64 participants.
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