NCT06767657 Urgent Carotid Endarterectomy (CEA) Versus Delayed CEA in Symptomatic Carotid Stenosis (SPREAD-STACI II)
| NCT ID | NCT06767657 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Italian Society of Vascular and Endovascular Surgery |
| Condition | Stroke, Ischemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 456 participants |
| Start Date | 2025-07-03 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 456 participants in total. It began in 2025-07-03 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06767657 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 90 Years, studying Stroke, Ischemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06767657 currently recruiting?
Yes, NCT06767657 is actively recruiting participants. Contact the research team at e.chisci@gmail.com for enrollment information.
Where is the NCT06767657 trial being conducted?
This trial is being conducted at Florence, Italy, Florence, Italy.
Who is sponsoring the NCT06767657 clinical trial?
NCT06767657 is sponsored by Italian Society of Vascular and Endovascular Surgery. The trial plans to enroll 456 participants.
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