Stroke, IschemicTime_to_sCEANCT06767657
Urgent Carotid Endarterectomy (CEA) Versus Delayed CEA in Symptomatic Carotid Stenosis (SPREAD-STACI II)
A study testing CEA (carotid endarterectomy) in people with Stroke, Ischemic and Transient Ischemic Accident, run by Italian Society of Vascular and Endovascular Surgery at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Stroke, Ischemic, Transient Ischemic Accident, Endarterectomy, Carotid
- What is being tested?
- CEA (carotid endarterectomy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 2 sitesItaly
- Study dates
- 3 Jul 2025to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Not yet recruiting
Usl Toscana Centro
Florence, 50143
Emiliano Chisci, MD, +39 3281970637, e.chisci@gmail.com
- Recruiting
Usl Toscana Centro
Florence
emiliano chisci, +39 3281970637, emiliano.chisci@ulscentro.toscana.it
About this study
Official title: Multicenter, Open-label Randomized Study Comparing Urgent Carotid Endarterectomy (CEA) (Within 72 Hours) Versus Delayed CEA (After 72 Hours) in Patients With Symptomatic Carotid Stenosis (SPREAD-STACI II)
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).
Read the detailed description
Background and Rationale
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 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).
Study Objectives
Primary Endpoint
To demonstrate that CEA for symptomatic ICA stenosis of 50% or greater (NASCET criteria) performed urgently within 72 hours of the onset of the ischemic symptom (TIA or minor stroke) is more effective than delayed CEA (performed after 72 hours but within 15 days) in reducing the risk of death, any type of stroke, and myocardial infarction within 90 days of the ischemic event.
Secondary Endpoints
To demonstrate that urgent CEA (within 72 hours of symptom onset) is more effective than delayed CEA (after 72 hours but within 15 days) in reducing the risk of ipsilateral ischemic stroke within 90 days of the ischemic event.
To identify potential subgroups of patients who benefit more from urgent CEA compared to delayed CEA.
To demonstrate that urgent CEA (within 72 hours) is as safe as delayed CEA (after 72 hours) in terms of the risk of cerebral hemorrhagic complications.
Study Design
This is a prospective, randomized, multicenter, controlled, non-profit interventional study with blinded follow-up at 90 days by the neurologist/internist investigator. The study is coordinated by the Vascular Surgery Unit (UOC) at San Giovanni di Dio Hospital, USL TOSCANA CENTRO, in collaboration with the Vascular Surgery Units listed above. All patients treated at the participating centers are eligible for inclusion if they meet the inclusion and exclusion criteria and provide informed consent to participate in the study.
The study does not introduce modifications or conflicts with standard clinical practice, as all enrolled and randomized patients (whether within or after 72 hours) will undergo surgical treatment (CEA) within 15 days of the index symptom, in accordance with national and international guidelines.
Study Population
Number of patients to be enrolled: 456
Withdrawal Criteria Patients may withdraw from the study at any time.
Interventions
The study will evaluate the same surgical procedure, carotid endarterectomy (CEA), which involves the removal of the atherosclerotic plaque causing thromboembolism or hemodynamically significant stenosis. This will be performed in two different timeframes:
Within 72 hours of the ischemic symptom. Between 72 hours and 14 days after the symptom.
The two study groups will not differ in the type of treatment offered but only in the timing of its execution.
No experimental procedures will be conducted. Whether CEA is performed within 72 hours or after this period, the surgical procedure will adhere fully to the current guidelines.
Assessment of Potential Benefit/Risk for the Study Population
The morbidity and mortality risk for the study participants is expected to be within the 6% limit for stroke/mortality at 30 days, as defined by the safety threshold in the literature and by national and international guidelines.
If this threshold (stroke/mortality at 30 days ≥ 6%) is exceeded in either group, the study will be terminated for safety reasons.
- Being tested
- CEA (carotid endarterectomy)
- Keywords
- stroke, endarterectomy, transient ischemic accident, stroke prevention
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEA (carotid endarterectomy)Procedure or surgery
Intervention (CEA) is associated to both arms (group A and B)
| Study group | Role | What they receive |
|---|---|---|
| Group A : Within 72 hours of the ischemic symptom | Experimental | The study will evaluate the same surgical procedure, carotid endarterectomy (CEA), which involves the removal of the atherosclerotic plaque causing thromboembolism or hemodynamically significant stenosis. This will be performed in two different timeframes:
GROUP A : Within 72 hours of the ischemic symptom. GROUP B: Between 72 hours and 14 days after the symptom.
The two study groups will not differ in the type of treatment offered but only in the timing of its execution.
No experimental procedures will be conducted. Whether CEA is performed within 72 hours or after this period, the surgical procedure will adhere fully to the current guidelines. Receives: Procedure: CEA (carotid endarterectomy) |
| Group B: Between 72 hours and 14 days after the ischemic symptom | Active comparator | see above Receives: Procedure: CEA (carotid endarterectomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment to 90 days follow-up from CEA
Secondary outcomes (2)
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)
Measured: From enrollment to 90 days follow-up from CEA
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.
Measured: From enrollment to 90 days follow-up from CEA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start3 Jul 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will evaluate the same surgical procedure, carotid endarterectomy (CEA), which involves the removal of the atherosclerotic plaque causing thromboembolism or hemodynamically significant stenosis. This will be performed in two different timeframes: Within 72 hours of the ischemic symptom. Between 72 hours and 14 days after the symptom. The two study groups will not differ in the type of treatment offered but only in the timing of its execution. No experimental procedures will be conducted. Whether CEA is performed within 72 hours or after this period, the surgical procedure will adhere fully to the current guidelines.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Italian Society of Vascular and Endovascular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMILIANO CHISCI, Italian Society of Vascular and Endovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767657
- Sponsor's protocol ID
- SPREAD STACI TRIAL II
- Acronym
- Time_to_sCEA
- Status last verified
- Mar 2026
- First submitted
- 23 Dec 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified Participant-Level Data: Informed consent templates , CRF Baseline clinical characteristics, including NIHSS score, comorbidities, and ASA score.) Diagnostic results related to carotid stenosis.Treatment details, including timing of CEA (urgent vs. delayed) and any perioperative interventions. Outcomes data, including: Incidence of stroke (all types), myocardial infarction, and death within 30 and 90 days.Neurological complications (e.g., ipsilateral ischemic stroke). Safety endpoints, including complications such as hemorrhagic stroke and other adverse events. Detailed study protocol outlining eligibility criteria, interventions, and endpoints. Statistical analysis plans used to to evaluate primary and secondary endpoints. Access will be granted after completion of the study and publication of the primary results.Requests must include a proposal for a secondary analysis, a data-sharing agreement, and a commitment to maintaining data confidentiality
Publications
Naylor AR. Occam's razor: Intervene early to prevent more strokes! J Vasc Surg. 2008 Oct;48(4):1053-9. doi: 10.1016/j.jvs.2008.06.044. Epub 2008 Aug 23.
PubMed 18723309Nordanstig A, Rosengren L, Stromberg S, Osterberg K, Karlsson L, Bergstrom G, Fekete Z, Jood K. Editor's Choice - Very Urgent Carotid Endarterectomy is Associated with an Increased Procedural Risk: The Carotid Alarm Study. Eur J Vasc Endovasc Surg. 2017 Sep;54(3):278-286. doi: 10.1016/j.ejvs.2017.06.017. Epub 2017 Jul 26.
PubMed 28755855Kakkos SK, Vega de Ceniga M, Naylor R. A Systematic Review and Meta-analysis of Peri-Procedural Outcomes in Patients Undergoing Carotid Interventions Following Thrombolysis. Eur J Vasc Endovasc Surg. 2021 Sep;62(3):340-349. doi: 10.1016/j.ejvs.2021.06.003. Epub 2021 Jul 12.
PubMed 34266765Coelho A, Peixoto J, Mansilha A, Naylor AR, de Borst GJ. Editor's Choice - Timing of Carotid Intervention in Symptomatic Carotid Artery Stenosis: A Systematic Review and Meta-Analysis. Eur J Vasc Endovasc Surg. 2022 Jan;63(1):3-23. doi: 10.1016/j.ejvs.2021.08.021. Epub 2021 Dec 23.
PubMed 34953681Stromberg S, Gelin J, Osterberg T, Bergstrom GM, Karlstrom L, Osterberg K; Swedish Vascular Registry (Swedvasc) Steering Committee. Very urgent carotid endarterectomy confers increased procedural risk. Stroke. 2012 May;43(5):1331-5. doi: 10.1161/STROKEAHA.111.639344. Epub 2012 Mar 15.
PubMed 22426315Loftus IM, Paraskevas KI, Johal A, Waton S, Heikkila K, Naylor AR, Cromwell DA. Editor's Choice - Delays to Surgery and Procedural Risks Following Carotid Endarterectomy in the UK National Vascular Registry. Eur J Vasc Endovasc Surg. 2016 Oct;52(4):438-443. doi: 10.1016/j.ejvs.2016.05.031. Epub 2016 Jun 28.
PubMed 27364857Naylor R, Rantner B, Ancetti S, de Borst GJ, De Carlo M, Halliday A, Kakkos SK, Markus HS, McCabe DJH, Sillesen H, van den Berg JC, Vega de Ceniga M, Venermo MA, Vermassen FEG, Esvs Guidelines Committee, Antoniou GA, Bastos Goncalves F, Bjorck M, Chakfe N, Coscas R, Dias NV, Dick F, Hinchliffe RJ, Kolh P, Koncar IB, Lindholt JS, Mees BME, Resch TA, Trimarchi S, Tulamo R, Twine CP, Wanhainen A, Document Reviewers, Bellmunt-Montoya S, Bulbulia R, Darling RC 3rd, Eckstein HH, Giannoukas A, Koelemay MJW, Lindstrom D, Schermerhorn M, Stone DH. Editor's Choice - European Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on the Management of Atherosclerotic Carotid and Vertebral Artery Disease. Eur J Vasc Endovasc Surg. 2023 Jan;65(1):7-111. doi: 10.1016/j.ejvs.2022.04.011. Epub 2022 May 20. No abstract available.
PubMed 35598721Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
PubMed 34024117Lanza G, Orso M, Alba G, Bevilacqua S, Capoccia L, Cappelli A, Carrafiello G, Cernetti C, Diomedi M, Dorigo W, Faggioli G, Giannace V, Giannandrea D, Giannetta M, Lanza J, Lessiani G, Marone EM, Mazzaccaro D, Migliacci R, Nano G, Pagliariccio G, Petruzzellis M, Plutino A, Pomatto S, Pulli R, Reale N, Santalucia P, Sirignano P, Ticozzelli G, Vacirca A, Visco E. Guideline on carotid surgery for stroke prevention: updates from the Italian Society of Vascular and Endovascular Surgery. A trend towards personalized medicine. J Cardiovasc Surg (Torino). 2022 Aug;63(4):471-491. doi: 10.23736/S0021-9509.22.12368-2.
PubMed 35848869Lanza G, Ricci S, Speziale F, Toni D, Sbarigia E, Setacci C, Pratesi C, Somalvico F, Zaninelli A, Gensini GF. SPREAD-STACI study: a protocol for a randomized multicenter clinical trial comparing urgent with delayed endarterectomy in symptomatic carotid artery stenosis. Int J Stroke. 2012 Jan;7(1):81-5. doi: 10.1111/j.1747-4949.2011.00699.x. Epub 2011 Dec 8.
PubMed 22151469
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label Randomized Study Comparing Urgent Carotid Endarterectomy (CEA) (Within 72 Hours) Versus Delayed CEA (After 72 Hours) in Patients With Symptomatic Carotid Stenosis (SPREAD-STACI II)
- ClinicalTrials.gov ID
- NCT06767657
- Acronym / sponsor ID
- Time_to_sCEA / SPREAD STACI TRIAL II
- Keywords
- stroke, endarterectomy, transient ischemic accident, stroke prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Italian Society of Vascular and Endovascular SurgeryUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Background and Rationale
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 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).
Study Objectives
Primary Endpoint
To demonstrate that CEA for symptomatic ICA stenosis of 50% or greater (NASCET criteria) performed urgently within 72 hours of the onset of the ischemic symptom (TIA or minor stroke) is more effective than delayed CEA (performed after 72 hours but within 15 days) in reducing the risk of death, any type of stroke, and myocardial infarction within 90 days of the ischemic event.
Secondary Endpoints
To demonstrate that urgent CEA (within 72 hours of symptom onset) is more effective than delayed CEA (after 72 hours but within 15 days) in reducing the risk of ipsilateral ischemic stroke within 90 days of the ischemic event.
To identify potential subgroups of patients who benefit more from urgent CEA compared to delayed CEA.
To demonstrate that urgent CEA (within 72 hours) is as safe as delayed CEA (after 72 hours) in terms of the risk of cerebral hemorrhagic complications.
Study Design
This is a prospective, randomized, multicenter, controlled, non-profit interventional study with blinded follow-up at 90 days by the neurologist/internist investigator. The study is coordinated by the Vascular Surgery Unit (UOC) at San Giovanni di Dio Hospital, USL TOSCANA CENTRO, in collaboration with the Vascular Surgery Units listed above. All patients treated at the participating centers are eligible for inclusion if they meet the inclusion and exclusion criteria and provide informed consent to participate in the study.
The study does not introduce modifications or conflicts with standard clinical practice, as all enrolled and randomized patients (whether within or after 72 hours) will undergo surgical treatment (CEA) within 15 days of the index symptom, in accordance with national and international guidelines.
Study Population
Number of patients to be enrolled: 456
Withdrawal Criteria Patients may withdraw from the study at any time.
Interventions
The study will evaluate the same surgical procedure, carotid endarterectomy (CEA), which involves the removal of the atherosclerotic plaque causing thromboembolism or hemodynamically significant stenosis. This will be performed in two different timeframes:
Within 72 hours of the ischemic symptom. Between 72 hours and 14 days after the symptom.
The two study groups will not differ in the type of treatment offered but only in the timing of its execution.
No experimental procedures will be conducted. Whether CEA is performed within 72 hours or after this period, the surgical procedure will adhere fully to the current guidelines.
Assessment of Potential Benefit/Risk for the Study Population
The morbidity and mortality risk for the study participants is expected to be within the 6% limit for stroke/mortality at 30 days, as defined by the safety threshold in the literature and by national and international guidelines.
If this threshold (stroke/mortality at 30 days ≥ 6%) is exceeded in either group, the study will be terminated for safety reasons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will evaluate the same surgical procedure, carotid endarterectomy (CEA), which involves the removal of the atherosclerotic plaque causing thromboembolism or hemodynamically significant stenosis. This will be performed in two different timeframes: Within 72 hours of the ischemic symptom. Between 72 hours and 14 days after the symptom. The two study groups will not differ in the type of treatment offered but only in the timing of its execution. No experimental procedures will be conducted. Whether CEA is performed within 72 hours or after this period, the surgical procedure will adhere fully to the current guidelines.
| Arm | Type | Receives |
|---|---|---|
| Group A : Within 72 hours of the ischemic symptom | Experimental | Procedure: CEA (carotid endarterectomy)The study will evaluate the same surgical procedure, carotid endarterectomy (CEA), which involves the removal of the atherosclerotic plaque causing thromboembolism or hemodynamically significant stenosis. This will be performed in two different timeframes: GROUP A : Within 72 hours of the ischemic symptom. GROUP B: Between 72 hours and 14 days after the symptom. The two study groups will not differ in the type of treatment offered but only in the timing of its execution. No experimental procedures will be conducted. Whether CEA is performed within 72 hours or after this period, the surgical procedure will adhere fully to the current guidelines. |
| Group B: Between 72 hours and 14 days after the ischemic symptom | Active comparator | Procedure: CEA (carotid endarterectomy)see above |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEA (carotid endarterectomy)Intervention (CEA) is associated to both arms (group A and B) | Procedure or surgery | Group A : Within 72 hours of the ischemic symptom, Group B: Between 72 hours and 14 days after the ischemic symptom |
Primary outcome
Number of participants with treatment-related death, any type of stroke, and myocardial infarction events as assessed by CTCAE v4.0
Time frame: From enrollment to 90 days follow-up from CEA
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)
2 secondary outcomes
Number of participants with treatment-related ipsilateral ischemic stroke events as assessed by CTCAE v4.0
Time frame: From enrollment to 90 days follow-up from CEA
Number of participants with treatment-related cerebral hemorrhagic events as assessed by CTCAE v4.0
Time frame: From enrollment to 90 days follow-up from CEA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Results publication: PubMed 18723309Naylor AR. Occam's razor: Intervene early to prevent more strokes! J Vasc Surg. 2008 Oct;48(4):1053-9. doi: 10.1016/j.jvs.2008.06.044. Epub 2008 Aug 23.
- Results publication: PubMed 28755855Nordanstig A, Rosengren L, Stromberg S, Osterberg K, Karlsson L, Bergstrom G, Fekete Z, Jood K. Editor's Choice - Very Urgent Carotid Endarterectomy is Associated with an Increased Procedural Risk: The Carotid Alarm Study. Eur J Vasc Endovasc Surg. 2017 Sep;54(3):278-286. doi: 10.1016/j.ejvs.2017.06.017. Epub 2017 Jul 26.
- Results publication: PubMed 34266765Kakkos SK, Vega de Ceniga M, Naylor R. A Systematic Review and Meta-analysis of Peri-Procedural Outcomes in Patients Undergoing Carotid Interventions Following Thrombolysis. Eur J Vasc Endovasc Surg. 2021 Sep;62(3):340-349. doi: 10.1016/j.ejvs.2021.06.003. Epub 2021 Jul 12.
- Results publication: PubMed 34953681Coelho A, Peixoto J, Mansilha A, Naylor AR, de Borst GJ. Editor's Choice - Timing of Carotid Intervention in Symptomatic Carotid Artery Stenosis: A Systematic Review and Meta-Analysis. Eur J Vasc Endovasc Surg. 2022 Jan;63(1):3-23. doi: 10.1016/j.ejvs.2021.08.021. Epub 2021 Dec 23.
- Results publication: PubMed 22426315Stromberg S, Gelin J, Osterberg T, Bergstrom GM, Karlstrom L, Osterberg K; Swedish Vascular Registry (Swedvasc) Steering Committee. Very urgent carotid endarterectomy confers increased procedural risk. Stroke. 2012 May;43(5):1331-5. doi: 10.1161/STROKEAHA.111.639344. Epub 2012 Mar 15.
- Results publication: PubMed 27364857Loftus IM, Paraskevas KI, Johal A, Waton S, Heikkila K, Naylor AR, Cromwell DA. Editor's Choice - Delays to Surgery and Procedural Risks Following Carotid Endarterectomy in the UK National Vascular Registry. Eur J Vasc Endovasc Surg. 2016 Oct;52(4):438-443. doi: 10.1016/j.ejvs.2016.05.031. Epub 2016 Jun 28.
- Results publication: PubMed 35598721Naylor R, Rantner B, Ancetti S, de Borst GJ, De Carlo M, Halliday A, Kakkos SK, Markus HS, McCabe DJH, Sillesen H, van den Berg JC, Vega de Ceniga M, Venermo MA, Vermassen FEG, Esvs Guidelines Committee, Antoniou GA, Bastos Goncalves F, Bjorck M, Chakfe N, Coscas R, Dias NV, Dick F, Hinchliffe RJ, Kolh P, Koncar IB, Lindholt JS, Mees BME, Resch TA, Trimarchi S, Tulamo R, Twine CP, Wanhainen A, Document Reviewers, Bellmunt-Montoya S, Bulbulia R, Darling RC 3rd, Eckstein HH, Giannoukas A, Koelemay MJW, Lindstrom D, Schermerhorn M, Stone DH. Editor's Choice - European Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on the Management of Atherosclerotic Carotid and Vertebral Artery Disease. Eur J Vasc Endovasc Surg. 2023 Jan;65(1):7-111. doi: 10.1016/j.ejvs.2022.04.011. Epub 2022 May 20. No abstract available.
- Results publication: PubMed 34024117Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
- Results publication: PubMed 35848869Lanza G, Orso M, Alba G, Bevilacqua S, Capoccia L, Cappelli A, Carrafiello G, Cernetti C, Diomedi M, Dorigo W, Faggioli G, Giannace V, Giannandrea D, Giannetta M, Lanza J, Lessiani G, Marone EM, Mazzaccaro D, Migliacci R, Nano G, Pagliariccio G, Petruzzellis M, Plutino A, Pomatto S, Pulli R, Reale N, Santalucia P, Sirignano P, Ticozzelli G, Vacirca A, Visco E. Guideline on carotid surgery for stroke prevention: updates from the Italian Society of Vascular and Endovascular Surgery. A trend towards personalized medicine. J Cardiovasc Surg (Torino). 2022 Aug;63(4):471-491. doi: 10.23736/S0021-9509.22.12368-2.
- Results publication: PubMed 22151469Lanza G, Ricci S, Speziale F, Toni D, Sbarigia E, Setacci C, Pratesi C, Somalvico F, Zaninelli A, Gensini GF. SPREAD-STACI study: a protocol for a randomized multicenter clinical trial comparing urgent with delayed endarterectomy in symptomatic carotid artery stenosis. Int J Stroke. 2012 Jan;7(1):81-5. doi: 10.1111/j.1747-4949.2011.00699.x. Epub 2011 Dec 8.
- Individual participant dataSharing planned: Yes. De-identified Participant-Level Data: Informed consent templates , CRF Baseline clinical characteristics, including NIHSS score, comorbidities, and ASA score.) Diagnostic results related to carotid stenosis.Treatment details, including timing of CEA (urgent vs. delayed) and any perioperative interventions. Outcomes data, including: Incidence of stroke (all types), myocardial infarction, and death within 30 and 90 days.Neurological complications (e.g., ipsilateral ischemic stroke). Safety endpoints, including complications such as hemorrhagic stroke and other adverse events. Detailed study protocol outlining eligibility criteria, interventions, and endpoints. Statistical analysis plans used to to evaluate primary and secondary endpoints. Access will be granted after completion of the study and publication of the primary results.Requests must include a proposal for a secondary analysis, a data-sharing agreement, and a commitment to maintaining data confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEA (carotid endarterectomy) in people with Stroke, Ischemic and Transient Ischemic Accident, run by Italian Society of Vascular and Endovascular Surgery at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EMILIANO CHISCI, MD (+39 3281970637, e.chisci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related death, any type of stroke, and myocardial infarction events as assessed by CTCAE v4.0 (time frame: From enrollment to 90 days follow-up from CEA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06767657, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.