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MENA Regional Endovascular Intervention for Venous Cerebral Venous Sinus Thrombosis
Sponsor: Middle East North Africa Stroke and Interventional Neurotherapies Organization
Summary
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.
Official title: REVIVE-CVST: A Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint (PROBE) Trial of Endovascular Thrombectomy Plus Standard Medical Care Versus Standard Medical Care Alone in Adults With Acute or Subacute Cerebral Venous Sinus Thrombosis at High Risk of Poor Outcome in the Middle East and North Africa Region
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
440
Start Date
2026-07
Completion Date
2030-01
Last Updated
2026-04-23
Healthy Volunteers
No
Conditions
Interventions
Endovascular Thrombectomy
Endovascular thrombectomy (EVT) performed within 24 hours of randomization. Techniques include mechanical thrombectomy using stent retrievers, aspiration thrombectomy, balloon-assisted thrombectomy, or a combination approach at the discretion of the treating neurointerventionalist. The procedure is performed under general anesthesia or conscious sedation via femoral venous access with navigation to the affected cerebral venous sinus.
Anticoagulation Therapy
Standard anticoagulation therapy consisting of intravenous unfractionated heparin (UFH) or subcutaneous low-molecular-weight heparin (LMWH) during the acute phase, followed by oral anticoagulation with warfarin (target INR 2.0-3.0) or direct oral anticoagulants (DOACs) for 3-12 months as per current AHA/ASA and ESO guidelines. Both arms receive this intervention.
Locations (14)
Alexandria University, Smouha Comprehensive Stroke Center
Alexandria, Egypt
Ain Shams University
Cairo, Egypt
Cairo University
Cairo, Egypt
Neurology Department, Al-Azhar University
Cairo, Egypt
Amman Specialized IR Center
Amman, Jordan
Centre Hospitalier Universitaire Ibn Sina de Rabat
Rabat, Morocco
Aga Khan University
Karachi, Pakistan
Weill Cornell Medicine-Qatar
Doha, Qatar
King Khalid University
Abhā, Saudi Arabia
King Abdulaziz Medical City
Jeddah, Saudi Arabia
King Abdullah Medical City
Mecca, Saudi Arabia
Institut National de Neurologie
Tunis, Tunisia
Department of Neurology, Eskisehir Osmangazi University
Eskişehir, Turkey (Türkiye)
Neurology Department, Dr. Lutfi Kirdar City Hospital
Istanbul, Turkey (Türkiye)