MENA Regional Endovascular Intervention for Venous Cerebral Venous Sinus Thrombosis

REVIVE-CVST is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial evaluating whether early endovascular thrombectomy (EVT) combined with standard anticoagulation improves outcomes compared to anticoagulation alone in patients with severe cerebral venous sinus thrombosis (CVST). The study targets adult patients (aged 18 years or older) presenting within 14 days of symptom onset with imaging-confirmed CVST and at least one severity marker, such as a Glasgow Coma Scale score of 14 or below, intracerebral hemorrhage, venous infarction, or deep venous system involvement. Participants will be randomly assigned in a 1:1 ratio to either the intervention arm (EVT plus anticoagulation) or the control arm (anticoagulation alone). The primary endpoint is functional outcome at 180 days as measured by the modified Rankin Scale (mRS), using a shift analysis across all mRS categories. The trial aims to enroll 440 participants across approximately 15 centers in the Middle East, North Africa, South Asia, and Turkey (MENA-SINO network). The study duration is approximately 42 months, including 18 months of enrollment and 12 months of follow-up for the last enrolled patient.

Inclusion Criteria: * Age 18-65 years, inclusive * Radiologically confirmed cerebral venous sinus thrombosis (CVST) by CT venography (CTV), MR venography (MRV), or digital subtraction angiography (DSA), with thrombosis of at least one major dural sinus * Acute or subacute presentation with symptom onset within 21 days of randomization * MRI phase characterization confirming acute or subacute phase * At least one risk factor for poor outcome: symptoms of intracranial hypertension (severe headache, papilledema, visual obscurations), focal neurological deficit, seizures, altered consciousness (GCS 9-14), intracranial hemorrhage from venous congestion, or deep venous system thrombosis * Significant venous outflow obstruction on imaging * Written informed consent from patient or legally authorized representative Exclusion Criteria: * Isolated cortical vein thrombosis without dural sinus involvement * Isolated cavernous sinus thrombosis * Chronic-phase CVST on MRI phase characterization * Pre-morbid modified Rankin Scale (mRS) score greater than 2 * Glasgow Coma Scale (GCS) score less than 9 at randomization * Imminent risk of transtentorial herniation requiring emergent decompressive craniectomy * Massive cerebral edema with midline shift greater than 10 mm requiring surgical intervention * Active systemic bleeding or hemorrhagic diathesis * Severe allergy to iodinated contrast media * CVST secondary to active hematological malignancy or life expectancy less than 12 months * Pregnancy * Participation in another interventional clinical trial within 30 days * Any condition rendering the patient unsuitable for study participation per investigator judgment