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

NCT06767657 | Recruiting

• 1 other identifier: SPREAD STACI TRIAL II
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 2

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).

Conditions

Stroke, Ischemic; Transient Ischemic Accident; Endarterectomy, Carotid; Stroke Prevention

Keywords

stroke; endarterectomy; transient ischemic accident; stroke prevention

Outcome Measures

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)

  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

  From enrollment to 90 days follow-up from CEA

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

  From enrollment to 90 days follow-up from CEA

Study Arms (2)

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.

Procedure: CEA (carotid endarterectomy)

Group B: Between 72 hours and 14 days after the ischemic symptom

ACTIVE COMPARATOR

see above

Procedure: CEA (carotid endarterectomy)

Interventions

CEA (carotid endarterectomy) PROCEDURE

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

Group A : Within 72 hours of the ischemic symptom; Group B: Between 72 hours and 14 days after the ischemic symptom

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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).

You may not qualify 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 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.

Sponsors & Collaborators

• Italian Society of Vascular and Endovascular Surgery: lead

Study Sites (2)

Usl Toscana Centro

Florence, 50143, Italy

NOT YET RECRUITING

Usl Toscana Centro

Florence, Italy

RECRUITING

Related Publications (10)

• 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.

  PMID: 18723309 RESULT

• Nordanstig 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.

  PMID: 28755855 RESULT

• Kakkos 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.

  PMID: 34266765 RESULT

• Coelho 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.

  PMID: 34953681 RESULT

• Stromberg 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.

  PMID: 22426315 RESULT

• Loftus 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.

  PMID: 27364857 RESULT

• Naylor 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.

  PMID: 35598721 RESULT

• Kleindorfer 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.

  PMID: 34024117 RESULT

• Lanza 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.

  PMID: 35848869 RESULT

• Lanza 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.

  PMID: 22151469 RESULT

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

EMILIANO CHISCI, MD

CONTACT

+39 3281970637; e.chisci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Endovascular Aortic UNIT, San Giovanni di Dio Hospital, USL Toscana Centro, Florence, ITALY

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 10, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: form January 2025 to December 2028
• Access Criteria: The IPD (Individual Participant Data) can be accessed by all members of the Italian Society of Vascular and Endovascular Surgery (SICVE) who submit a direct access request via the SICVE web address at https://www.anughea.ai/wp-login.php.

Locations

IT (2)