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Urgent Carotid Endarterectomy (CEA) Versus Delayed CEA in Symptomatic Carotid Stenosis (SPREAD-STACI II)
Sponsor: Italian Society of Vascular and Endovascular Surgery
Summary
In patients with internal carotid artery (ICA) stenosis of 50% or greater (measured according to the criteria of the North American Symptomatic Carotid Endarterectomy Trial (NASCET)) who have experienced a transient ischemic attack (TIA) or minor ipsilateral stroke, carotid endarterectomy (CEA) offers maximum benefit if performed within 15 days of the initial ischemic symptom. National and international guidelines recommend surgical treatment (CEA) within this timeframe; however, no studies have specifically evaluated the optimal timing for CEA after a TIA or minor stroke. It is well established that the risk of a major stroke is highest in the first few days following a transient ischemic attack or minor stroke and then decreases over the subsequent days and weeks. This raises the hypothesis that performing an urgent carotid endarterectomy (within 3 days) may provide greater benefit compared to a delayed procedure (between 4 and 15 days).
Official title: Multicenter, Open-label Randomized Study Comparing Urgent Carotid Endarterectomy (CEA) (Within 72 Hours) Versus Delayed CEA (After 72 Hours) in Patients With Symptomatic Carotid Stenosis (SPREAD-STACI II)
Key Details
Gender
All
Age Range
45 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
456
Start Date
2025-07-03
Completion Date
2028-01-01
Last Updated
2026-03-04
Healthy Volunteers
No
Interventions
CEA (carotid endarterectomy)
Intervention (CEA) is associated to both arms (group A and B)
Locations (2)
Usl Toscana Centro
Florence, Italy
Usl Toscana Centro
Florence, Italy