RecruitingNot Applicable

Urgent Carotid Endarterectomy (CEA) Versus Delayed CEA in Symptomatic Carotid Stenosis (SPREAD-STACI II)

Italy456 participantsStarted 2025-07-03

Plain-language 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).

Who can participate

Age range45 Years – 90 Years

SexALL

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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 thrombect…

What they're measuring

Number of participants with treatment-related death, any type of stroke, and myocardial infarction events as assessed by CTCAE v4.0

Timeframe: From enrollment to 90 days follow-up from CEA

Trial details

NCT IDNCT06767657

SponsorItalian Society of Vascular and Endovascular Surgery

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-01

Contact for this trial

EMILIANO CHISCI, MD

+39 3281970637 e.chisci@gmail.com