Combined Recanalization Therapy for Acute Large Vessel Occlusion Stroke (CRTALVOS)

Tianjin Huanhu Hospital

Status: Enrolling

Conditions: Stroke

Treatments: Procedure: Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07115511

CRTALVOS2025

tianjin Huanhu hospital (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

experiment group（surgical treatment）

Experimental group

Treatment:

Procedure: Surgery

control group（conservative therapy）

No Intervention group