Actively Recruiting
Urgent Carotid Endarterectomy (CEA) Versus Delayed CEA in Symptomatic Carotid Stenosis (SPREAD-STACI II)
Led by Italian Society of Vascular and Endovascular Surgery · Updated on 2026-03-04
456
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Urgent Carotid Endarterectomy (CEA) Versus Delayed CEA in Symptomatic Carotid Stenosis (SPREAD-STACI II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Carotid artery narrowing of 50% or more by NASCET method diagnosed by ultrasound, MRA, CTA, or catheter angiography
- Transient ischemic attack (TIA) or minor stroke (NIHSS score 5 or less) on the same side within the last 24 hours
- Preserved consciousness and stable neurological symptoms with no ongoing brain ischemia or ischemic area less than 25 mm
- Age between 45 and 90 years
- ASA score less than 4
- Ability to comply with follow-up requirements
- Willingness to provide informed consent
- Patients who had thrombolysis and/or mechanical thrombectomy with no secondary brain hemorrhage on CT or MRI
You will not qualify if you...
- Carotid artery narrowing less than 50% by NASCET method
- Carotid artery thrombosis or dissection
- NIHSS score greater than 5
- Cerebral hemorrhage
- Impaired consciousness or unstable neurological condition
- Cancer or other conditions with poor prognosis
- Major heart disease or severe neurological disorders
- Brain ischemic area greater than 25 mm on CT or MRI
- Brain lesions of uncertain cause on CT or MRI
- Recurrent TIA or stroke in evolution
- Age younger than 45 or older than 90 years
- ASA risk score equal to 4
- Lack of informed consent
- Inability to have surgery within 72 hours of symptom onset
- Inability to attend 90-day follow-up
- Previous carotid endarterectomy or stenting on the affected artery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Usl Toscana Centro
Florence, Italy, 50143
Not Yet Recruiting
2
Usl Toscana Centro
Florence, Italy
Actively Recruiting
Research Team
E
EMILIANO CHISCI, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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