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

Launched by ITALIAN SOCIETY OF VASCULAR AND ENDOVASCULAR SURGERY · Jan 4, 2025

Keywords

ClinConnect Summary

The SPREAD-STACI II trial is studying the best timing for a surgical procedure called carotid endarterectomy (CEA) in patients who have a narrowing of the carotid artery and have recently experienced a transient ischemic attack (TIA) or a minor stroke. This surgery can help prevent major strokes, and the trial is specifically looking at whether performing the surgery urgently, within 3 days of the initial symptoms, is more beneficial than doing it later, between 4 and 15 days.

To be eligible for this trial, participants should be between 45 and 90 years old and have a carotid artery narrowing of 50% or more. They must have had a TIA or a minor stroke with mild symptoms and be stable at the time of enrollment. Participants can expect to be monitored closely and will need to follow up for 90 days after the procedure. This trial is important because it aims to provide clearer guidelines on how quickly surgery should be performed after these serious events to help improve patient outcomes.

Gender

ALL

Eligibility 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.