Urgent versus delayed carotid endarterectomy after a TIA or minor stroke
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)
Run by Italian Society of Vascular and Endovascular Surgery · NCT06767657 · Data updated 2026-11-12
This trial tests whether doing carotid endarterectomy within 3 days instead of waiting 4–15 days better prevents death, stroke, or heart attack in adults 45–90 with symptomatic carotid narrowing after a TIA or minor stroke.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 90 Years |
| Sex | All |
| Enrollment | 456 (estimated) |
| Sponsor | Italian Society of Vascular and Endovascular Surgery Academic / other |
| Locations | 2 sites (Florence and 1 other locations) |
| Status | Recruiting |
| Started | July 3, 2025 |
| Main results expected | September 1, 2027 |
| Study ends | January 1, 2028 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT06767657 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 45–90 with ipsilateral carotid stenosis ≥50% (NASCET), a recent TIA or minor stroke within the prior 24 hours, NIHSS ≤5, neurologically stable symptoms, and ability to provide consent are ideal candidates.
✕Probably not a fit
Patients with major disabling stroke (NIHSS >5), ongoing large cerebral ischemia, severe comorbidities (e.g., ASA ≥4), or asymptomatic carotid disease are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with ipsilateral internal carotid artery stenosis of 50% or greater (NASCET criteria) who recently had a TIA or minor stroke and are neurologically stable are enrolled. Participants undergo carotid endarterectomy either urgently (within 72 hours of the ischemic symptom) or delayed (after 72 hours but within 15 days). Key inclusion features include NIHSS ≤5, preserved consciousness, and imaging confirmation of stenosis by ultrasound, CTA, MRA, or angiography. The main outcome is a composite of death, any stroke, and myocardial infarction within 90 days of the ischemic event.
Why it matters
Potential benefit: If successful, the study could identify whether earlier surgery reduces the risk of early recurrent major stroke, death, or heart attack.
How similar studies have gone: Guidelines already recommend CEA within 15 days and observational data show highest recurrent stroke risk in the first days after symptoms, but no prior randomized data have specifically compared urgent (≤72 h) versus delayed (4–15 d) CEA, making this a relatively novel timing comparison.
Who can join: the full rules
Show full inclusion / exclusion criteria
Eligibility Criteria Inclusion Criteria: Patients presenting with the following characteristics: De novo stenosis of the carotid bifurcation and/or internal carotid artery origin, equal to or greater than 50% (NASCET method), diagnosed by color Doppler ultrasound, MR angiography (MRA), CT angiography (CTA), or catheter angiography. TIA or minor ischemic stroke (NIHSS ≤ 5) ipsilateral to the carotid stenosis, occurring within the previous 24 hours. Preserved consciousness and neurologically stable symptoms. No evidence of ongoing cerebral ischemia, or evidence of cerebral ischemia with a diameter \<25 mm. Age between 45 and 90 years. ASA score \< 4. Ability to comply with follow-up requirements as specified. Willingness to provide informed consent for participation in the study. A patient with an NIHSS ≤ 5 who is aphasic may be unable to provide consent. In these cases: The attending physician assesses the feasibility of including the patient. Family members are informed but, under Italian law, cannot provide consent. A third-party physician certifies that the patient meets the inclusion criteria. The attending physician signs the appropriate form, and randomization proceeds. If and when the patient regains the ability to provide or refuse consent, the informed consent form will be presented to them. Should they decline, their data will be removed from the study database. Additionally, the study includes patients who underwent thrombolysis and/or mechanical thrombectomy after the onset of the index symptom, followed by a brain CT/MRI without secondary cerebral hemorrhage (PH1, PH2, or PHr). Exclusion Criteria: Stenosis \< 50% (NASCET method) at the bifurcation and/or internal carotid artery origin, diagnosed by ECD, CTA, or MRA. Carotid thrombosis or dissection. NIHSS \> 5. Cerebral hemorrhage. Impaired consciousness or neurologically unstable condition. Cancer, any condition with a poor prognosis, major cardiopathy, or any severe neurological disorder. CT or MRI evidence of cerebral ischemia \> 25 mm in diameter. CT or MRI evidence of cerebral lesions of uncertain origin. Recurrent TIA or stroke-in-evolution. Age \< 45 years or \> 90 years. ASA risk score = 4. Lack of informed consent. Inability to undergo CEA within 72 hours of the initial ischemic symptom. Inability to participate in a 90-day follow-up after the initial ischemic symptom. Previous CEA or stenting of the examined carotid artery.
Where it's running
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Usl Toscana Centro
Florence, Italy Recruiting -
Usl Toscana Centro
Florence, Italy Not yet recruiting
Study contacts
- Study coordinator: Emiliano Chisci, Md
- Email: e.chisci@gmail.com
- Phone: +39 3281970637
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.