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Compares treatment options for Stroke, Ischemic
Official title Urgent Carotid Endarterectomy (CEA) Versus Delayed CEA in Symptomatic Carotid Stenosis (SPREAD-STACI II)
ClinicalTrials.gov ID: NCT06767657
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 90
You may be able to join if
- Eligibility 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...
- 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...
You likely can't join if
- 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...
- CT or MRI evidence of cerebral ischemia \> 25 mm in diameter. CT or MRI evidence of cerebral lesions of uncertain origin. Recurrent TIA or...
- Previous CEA or stenting of the examined carotid artery.
See the full eligibility criteria
- Eligibility 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...
- 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 .
- 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...
- 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...
- 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...
- 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 \ 90 years. ASA risk score = 4. Lack of informed...
- Previous CEA or stenting of the examined carotid artery.
The study team makes the final eligibility decision.
Where it's taking place
- Florence, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Florence, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.