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Timing of Carotid Artery Surgery After a Mini-Stroke or Warning Stroke

Compares surgery to clear a narrowed neck artery within 72 hours versus after 72 hours.

Key facts

Who runs it
Italian Society of Vascular and Endovascular Surgery
Where
Florence, ItalySee the site
Trial code
Registry title
Urgent Carotid Endarterectomy (CEA) Versus Delayed CEA in Symptomatic Carotid Stenosis (SPREAD-STACI II)
Status
Recruiting
People taking part
456 people, planned
Started
3 Jul 2025
Expected to end
1 Jan 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • CEA (carotid endarterectomy)
Record updated
4 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 45 to 90 with a narrowed carotid artery who had a TIA or a minor stroke in the last 24 hours. It compares urgent surgery with delayed surgery.

Age
45 to 90 years
Sex
All sexes
Disease stage
New narrowing of the carotid artery of 50% or more (NASCET method), on the same side as a TIA or minor ischemic stroke (NIHSS 5 or lower) in the previous 24 hours. Symptoms must be stable and consciousness preserved. Any brain damage from the stroke must be smaller than 25 mm.
Earlier treatment
People who had clot-busting treatment or mechanical clot removal can join if a later brain scan shows no secondary brain bleeding. People with a previous CEA or stent in this carotid artery cannot join.

Main reasons for not taking part

  • Narrowing under 50%
  • Carotid thrombosis or dissection
  • Brain bleeding, or NIHSS above 5
  • Recurrent TIA or stroke in evolution
  • Cancer or other condition with a poor prognosis, major heart disease or severe neurological disorder

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Previous CEA or stenting of the examined carotid artery
  • 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
  • Stenosis < 50% (NASCET method) at the bifurcation and/or internal carotid artery origin, diagnosed by ECD, CTA, or MRA

Other criteria

  • Eligibility Criteria

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 45 and 90 years old?

Where in Italy

  • Usl Toscana CentroFlorence, ItalyContact: Emiliano Chisci, MDNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 2 groups in the trial

  • Group A : Within 72 hours of the ischemic symptomTreatment being tested

    The study will evaluate the same surgical procedure, carotid endarterectomy (CEA), which involves the removal of the atherosclerotic plaque causing thromboembolism or hemodynamically significant stenosis. This will be performed in two different timeframes: GROUP A : Within 72 hours of the ischemic symptom. GROUP B: Between 72 hours and 14 days after the symptom. The two study groups will not differ in the type of treatment offered but only in the timing of its execution. No experimental procedures will be conducted. Whether CEA is performed within 72 hours or after this period, the surgical procedure will adhere fully to the current guidelines.

    Treatment: CEA (carotid endarterectomy)

  • Group B: Between 72 hours and 14 days after the ischemic symptomExisting treatment, for comparison

    see above

    Treatment: CEA (carotid endarterectomy)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Timing of Carotid Artery Surgery After a Mini-Stroke or Warning StrokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06767657, who can take part
Record updated
4 March 2026