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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-90
SponsorItalian Society of Vascular and Endovascular Surgery

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • CEA (carotid endarterectomy)

    Procedure/Surgery

    Intervention (CEA) is associated to both arms (group A and B)

Treatment groups

456 Participants
are divided into 2 treatment groups
Group A: Group A : Within 72 hours of the ischemic symptomExperimental treatment 1 intervention
Group B: Group B: Between 72 hours and 14 days after the ischemic symptomActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Number of patients experiencing death, any type of stroke, and myocardial infarction within 90 days of the ischemic event in group A and B (numerical values)

Time frame
From enrollment to 90 days follow-up from CEA

Secondary outcomes

1

Number of participants with treatment-related ipsilateral ischemic stroke events as assessed by CTCAE v4.0

Number of patients experiencing ipsilateral ischemic stroke within 90 days of the ischemic event in group A and B. (numerical values)

Time frame
From enrollment to 90 days follow-up from CEA
2

Number of participants with treatment-related cerebral hemorrhagic events as assessed by CTCAE v4.0

To demonstrate that urgent CEA (within 72 hours) is as safe as delayed CEA (after 72 hours) in terms of number of cerebral hemorrhagic events.

Time frame
From enrollment to 90 days follow-up from CEA

Other outcomes

Sponsors and contacts

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