Combined recanalization for acute large-vessel occlusion when standard methods fail

Combined Recanalization Therapy for Acute Large Vessel Occlusion Stroke

This tests whether combining arteriotomy, thrombectomy, and cerebrovascular bypass can improve recovery for adults with acute large-vessel ischemic stroke when mechanical thrombectomy fails.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Huanhu Hospital (other)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07115511 on ClinicalTrials.gov

What this trial studies

Adults (18–75) with acute middle cerebral artery occlusion (with or without internal carotid involvement) who meet mechanical thrombectomy indications but have unsuccessful MT (TICI 0–1) and favorable imaging (ASPECTS ≥6 or mismatch) may undergo combined recanalization procedures including arteriotomy, additional thrombectomy, or cerebrovascular bypass within 24 hours of onset. The primary outcome is the proportion of participants achieving a modified Rankin Scale score of 0–1 at 90 days, with perioperative safety monitoring. The intervention is surgical and performed at Tianjin Huanhu Hospital for eligible patients. The trial aims to determine whether these combined surgical approaches can increase good functional outcomes in patients who cannot be recanalized by standard methods.

Who should consider this trial

Good fit: Adults 18–75 with acute MCA (± ICA) large-vessel occlusion who had unsuccessful mechanical thrombectomy (TICI 0–1), ASPECTS ≥6 or imaging mismatch, baseline mRS ≤2, and craniotomy expected within 24 hours are the intended candidates.

Not a fit: Patients with recent myocardial infarction or unstable cardiac disease, bleeding or hematologic disorders, pregnancy, prior intracranial/extracranial bypass, other cerebrovascular lesions that alter hemodynamics, or limited life expectancy are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the approach could increase the chance of a good recovery (mRS 0–1) at 90 days for patients who cannot be reopened with standard thrombectomy.

How similar studies have performed: Combined surgical recanalization for this specific scenario is relatively novel and there are limited prior trials showing clear success.

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.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Huahu Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Gao Kaiming

Conditions: Stroke