Carotid Endarterectomy and Stenting Timing

NCT06898151 | Recruiting DMC

• 1 other identifier: CEST
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the safety and efficacy of carotid revascularization performed within 48 hours versus after 14 days in patients with symptomatic carotid stenosis accompanied with MRI-confirmed acute infarction (high signal on diffusion-weighted imaging accompanied by low apparent diffusion coefficient signal) in the responsible vascular territory.

Conditions

Carotid Endarterectomy; Carotid Stenting

Keywords

Timing of carotid artery revascularization

Outcome Measures

Primary Outcomes (1)

• Any stroke, death, myocardial infarction, or urgent revascularization from randomization to 30 days, or an ischemic stroke in the responsible vascular territory occurring between 30 days and 3 months post-randomization.

  Urgent revascularization indicates the rescue surgery when transient ischemic attack happened during medical treatment. TIA: any temporary neurological deficit lasting less than 24 hours confirmed by a certified neurologist. Stroke including ischemic and hemorrhagic stroke within the territory of the treated carotid artery as confirmed by cerebral MRI or CT. All cause death will be confirmed when mRS scale is 6. Myocardial infarction: detection of rise and/or fall of cardiac biomarkers with at least one value above the 99th percentile of the upper reference limit together with evidence of myocardial ischaemia with at least one of the following: symptoms of ischaemia, ECG changes indicative of new ischaemia (new ST-T changes or new left bundle branch block, new onset of pathological Q waves in ECG, imaging evidence of new loss of viable myocardium or new regional wall motion abnormolity.

  From randomization to 3 months

Secondary Outcomes (15)

• Ischemic stroke in the responsible vascular territory

  30 days and 3 months post-randomization

• Any stroke

  from randomization to 3 months post-randomization

• Disabling stroke (mRS>3)

  from randomization to 3 months

• Fatal stroke

  from randomization to 3months

• Hemorrhagic stroke

  from randomization to 3 months

Study Arms (2)

CEA/CAS within 48 hours after randomization

EXPERIMENTAL

All the participants in this group will be performed with CEA/CAS plus best medical treatment including Aspirin 100mg per day + Clopidogrel 75mg per day or Ticagrelor 90mg twice per day before surgery. If CEA was assigned, mono anti-platelet therapy will be performed thereafter. If CAS was assigned, dual-antiplatelet will be performed for 3 months after surgery followed by mono anti-platelet therapy thereafter. CAS or CAS will be performed within 48h after randomization.

Procedure: CEA/CAS plus best medical treatment

CEA/CAS after 14 days of randomization

OTHER

All the participants in this group will be performed with CEA/CAS plus best medical treatment including Aspirin 100mg per day + Clopidogrel 75mg per day or Ticagrelor 90mg twice per day before surgery. If CEA was assigned, mono anti-platelet therapy will be performed thereafter. If CAS was assigned, dual-antiplatelet will be performed for 3 months after surgery followed by mono anti-platelet therapy thereafter. CEA or CAS will be performed 14 days after randomization.

Procedure: CEA/CAS plus best medical treatment

Interventions

CEA/CAS plus best medical treatment PROCEDURE

Timing of CEA/CAS plus best medical treatment

CEA/CAS after 14 days of randomization; CEA/CAS within 48 hours after randomization

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years;
• Diagnosed with symptomatic carotid stenosis, defined as the occurrence of sudden-onset neurological symptoms within the territory of the responsible artery within 180 days before randomization (e.g., contralateral hemiparesis, slurred speech/difficulty in expression, ipsilateral monocular vision loss, etc.);
• Stenosis located in the extracranial segment of the internal carotid artery (with or without involvement of the adjacent common carotid artery);
• Degree of stenosis in the responsible carotid artery confirmed to be ≥50% and ≤99% by CTA/MRA/DSA, based on NASCET criteria;
• Brain MRI within 72 hours before randomization indicating an acute infarction in the responsible vascular territory, characterized by high signal on DWI and low signal on ADC;
• Modified Rankin Scale (mRS) score \<3;
• Written informed consent obtained from the patient or their legal representative.

You may not qualify if:

• Progressive neurological deterioration within 72 hours before randomization, defined as an increase in mRS score by ≥2 points or NIHSS score by ≥4 points;
• Brain MRI within 72 hours before randomization indicating a large infarction (infarct size \> 1/2 of the middle cerebral artery territory);
• MRI evidence of hemorrhagic cerebrovascular diseases (e.g., brain tumor, brain abscess, vascular malformations) or other non-ischemic cerebrovascular diseases (e.g., multiple sclerosis);
• Non-atherosclerotic carotid stenosis (e.g., carotid artery dissection, carotid web, floating thrombus, fibromuscular dysplasia, Takayasu arteritis, etc.);
• Need for simultaneous surgical intervention for tandem lesions in the ipsilateral carotid artery or other vascular surgeries;
• History of cerebrovascular surgery within 6 months before randomization;
• Coexisting cerebrovascular stenosis requiring revascularization within 3 months after randomization;
• History of spontaneous intracranial hemorrhage within 12 months before randomization;
• Clear indication for anticoagulation therapy (suspected cardiac embolic source such as atrial fibrillation, known mechanical heart valve, or suspected infective endocarditis);
• Laboratory abnormalities, including white blood cell count \< 2×10⁹/L, hematocrit \< 30%, platelet count \< 100×10⁹/L, INR \> 1.5, or heparin-induced thrombocytopenia;
• Inability to use antiplatelet therapy due to specific reasons, such as active gastrointestinal ulcers, gastrointestinal bleeding within the past 3 months, known severe allergy, severe renal insufficiency (creatinine \>1.5 times the normal upper limit), hepatic dysfunction (ALT or AST \>2 times the normal upper limit), or severe heart failure (NYHA Class III-IV);
• Presence of other severe diseases that may affect adherence to the study protocol, such as severe infection, advanced chronic obstructive pulmonary disease (COPD), active malignant tumors, dementia, psychiatric disorders, or uncontrolled severe hypertension;
• Pregnant or breastfeeding women who are not in menopause;
• Participation in another investigational device or drug trial that may interfere with this study;
• Any other medical condition or history that, in the investigator's judgment, may affect the efficacy or safety assessment of the study.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University.

Beijing, China

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• Rothwell PM, Eliasziw M, Gutnikov SA, Warlow CP, Barnett HJ; Carotid Endarterectomy Trialists Collaboration. Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery. Lancet. 2004 Mar 20;363(9413):915-24. doi: 10.1016/S0140-6736(04)15785-1.

  PMID: 15043958 BACKGROUND

Central Study Contacts

Yan Prof. Ma, MD

CONTACT

+86 15001376121; xrqssq@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 27, 2025
• Study Start: March 7, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

CN (1)