Carotid EndarterectomyCESTNCT06898151
Carotid Endarterectomy and Stenting Timing
A study testing CEA/CAS plus best medical treatment in people with Carotid Endarterectomy and Carotid Stenting, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Endarterectomy, Carotid Stenting
- What is being tested?
- CEA/CAS plus best medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2025to 1 Sep 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University.
Beijing
Yan Ma, MD., +86 15001376121, xrqssq@126.com
About this study
Official title: Carotid Endarterectomy and Stenting Timing：The CEST Trial
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.
Read the detailed description
Carotid artery stenosis is an important cause of stroke, and about 20-30% of ischemic stroke can be attributed to carotid artery stenosis. In the past 20 years, the prevalence of carotid artery stenosis in my country has increased by 70.07%, which has imposed a heavy burden on the national economy and society. At present, for symptomatic carotid artery stenosis, carotid artery revascularization, mainly carotid endarterectomy (CEA) and carotid artery stenting (CAS), combined with optimal drug therapy (antiplatelet + lipid-lowering), has become the mainstream treatment. In 2004, Rothwell et al. conducted a meta-analysis of individual case data from the European Carotid Surgery Trial (ECST) and the North American Symptomatic Carotid Endarterectomy Trial (NASCET). The results showed that when the waiting time between the onset of symptoms and the receipt of revascularization was prolonged, the effect of carotid artery revascularization in preventing future strokes would be significantly weakened. The latest guidelines issued by the European Stroke Organisation (ESO) recommend that 50-99% of patients with symptomatic carotid stenosis undergo acute CEA, preferably within 14 days after the ischemic event. Based on these clinical research evidence, an increasing number of patients have undergone acute CEA over the past two decades. For example, a study in the United States confirmed that the median waiting time from the occurrence of an ischemic event to receiving CEA decreased from 22 days in 2009 to 12 days in 2014, and the proportion of patients treated within the 14-day interval increased from 37% to 58%. Similarly, data from Germany from 2003 to 2014 showed that the interval from the ischemic event to receiving CEA decreased from 28 days to 8 days. Despite this, in China, the proportion of patients who received carotid revascularization within 14 days is still relatively low due to concerns about increased perioperative complications of acute revascularization.
Previously, the investigators retrospectively analyzed 1172 patients with symptomatic carotid stenosis, and used diffusion-weighted imaging (DWI) and apparent diffusion coefficient (ADC) sequences to identify whether there was acute new infarction before surgery. Further analysis found that for patients with symptomatic carotid stenosis combined with acute new infarction, regardless of the type of revascularization (CEA or CAS), the risk of postoperative serious adverse events was significantly increased. Therefore, for patients with preoperative new infarction on MRI, the investigators urgently need more effective treatment strategies to reduce the incidence of postoperative adverse events and improve the long-term prognosis of patients. The discussion of the timing of surgery is an important part of the treatment strategy. However, there is no large-scale clinical study report on whether preoperative new infarction on MRI has an auxiliary effect on the optimal timing of surgery for symptomatic carotid artery stenosis. Therefore, the investigators plan to initiate a multicenter, prospective, randomized, open-label, blinded RCT trial to explore whether preoperative new infarction on MRI can serve as a new marker for the safety and effectiveness of revascularization surgery in patients with symptomatic carotid artery stenosis.
- Conditions
- Carotid Endarterectomy, Carotid Stenting
- Being tested
- CEA/CAS plus best medical treatment
- Keywords
- Timing of carotid artery revascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEA/CAS plus best medical treatmentProcedure or surgery
Timing of CEA/CAS plus best medical treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: CEA/CAS plus best medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to 3 months
Secondary outcomes (15)
Ischemic stroke in the responsible vascular territory
The ischemic stroke will be confirmed when infarction of responsible vascular territory could be identified on cerebral MRI or CT.
Measured: 30 days and 3 months post-randomization
Any stroke
The ischemic or hemorrhagic stroke will be confirmed by cerebral MRI or CT.
Measured: from randomization to 3 months post-randomization
Disabling stroke (mRS>3)
The modified Rankin Scale (mRS) will be used to define this outcome. The disabling stroke is confirmed when mRS>3. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials.
Measured: from randomization to 3 months
Fatal stroke
Ischemic or hemorrhagic stroke (confirmed on cerebral MRI) leading to death.
Measured: from randomization to 3months
Hemorrhagic stroke
The hemorrhagic stroke need to be confirmed by cerebral MRI or CT
Measured: from randomization to 3 months
Death
All cause of death as confirmed by mRS=6.
Measured: from randomization to 3 months
Any stroke, death, myocardial infarction
Stroke: Including ischemic and hemorrhagic stroke as confirmed by cerebral CT or MRI.
Death: All cause of death as confirmed by mRS=6. Myocardial infarction: detection of rise and/or fall of cardiac biomarkers (preferable troponin) with at least one value above the 99th percentile of the upper reference limit together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia, ECG changes indicative of new ischemia (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 abnormality).
Measured: from randomization to 3 months
Myocardial infarction
Myocardial infarction: detection of rise and/or fall of cardiac biomarkers (preferable troponin) with at least one value above the 99th percentile of the upper reference limit together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia, ECG changes indicative of new ischemia (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 abnormality)
Measured: from randomization to 3 months
Proportional distribution of mRS/NIHSS
The mRS score range from 0 (no disability) to 6 (death); the NIHSS score range from 0 (no disability) to 42 (severely disabled).
Measured: 3 months post-randomization
EQ-5D-5L
The EQ-5D 5-Levels (EQ-5D-5L) range from 5 (no problems) to 25 (extreme problems), which deceased patients have a utility of 0.
Measured: 3 months post-randomization
Rehospitalization
Times of rehospitalization.
Measured: from randomization to 3 months
Ischemic stroke or urgent revascularization
Ischemic stroke will be confirmed by cerebral CT or MRI. Urgent revascularization indicated to those who suffered from transient ischemic stroke (TIA) and received urgent surgery. TIA: any temporary neurological deficit lasting less than 24 hours confirmed by a certified neurologist.
Measured: Randomization to surgery
Any stroke, death and myocardial infarction
Stroke: Including ischemic and hemorrhagic stroke as confirmed by cerebral CT or MRI. Death: All cause of death as confirmed by mRS=6. Myocardial infarction: detection of rise and/or fall of cardiac biomarkers (preferable troponin) with at least one value above the 99th percentile of the upper reference limit together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia, ECG changes indicative of new ischemia (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 abnormality).
Measured: surgery to 30 days
Average hospital stay
The average days of hospital stay will be recorded and the proportion will be presented.
Measured: from randomization to 3 months
Average hospital cost
The average cost before reimbursement will be recorded and the proportion will be presented.
Measured: from randomization to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start7 Mar 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carotid EndarterectomyStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898151
- Sponsor's protocol ID
- CEST
- Acronym
- CEST
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35598721Rothwell 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.
PubMed 15043958
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Endarterectomy and Stenting Timing：The CEST Trial
- ClinicalTrials.gov ID
- NCT06898151
- Acronym / sponsor ID
- CEST / CEST
- Conditions
- Carotid Endarterectomy, Carotid Stenting
- Keywords
- Timing of carotid artery revascularization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 Mar 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.
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.
Detailed description
Carotid artery stenosis is an important cause of stroke, and about 20-30% of ischemic stroke can be attributed to carotid artery stenosis. In the past 20 years, the prevalence of carotid artery stenosis in my country has increased by 70.07%, which has imposed a heavy burden on the national economy and society. At present, for symptomatic carotid artery stenosis, carotid artery revascularization, mainly carotid endarterectomy (CEA) and carotid artery stenting (CAS), combined with optimal drug therapy (antiplatelet + lipid-lowering), has become the mainstream treatment. In 2004, Rothwell et al. conducted a meta-analysis of individual case data from the European Carotid Surgery Trial (ECST) and the North American Symptomatic Carotid Endarterectomy Trial (NASCET). The results showed that when the waiting time between the onset of symptoms and the receipt of revascularization was prolonged, the effect of carotid artery revascularization in preventing future strokes would be significantly weakened. The latest guidelines issued by the European Stroke Organisation (ESO) recommend that 50-99% of patients with symptomatic carotid stenosis undergo acute CEA, preferably within 14 days after the ischemic event. Based on these clinical research evidence, an increasing number of patients have undergone acute CEA over the past two decades. For example, a study in the United States confirmed that the median waiting time from the occurrence of an ischemic event to receiving CEA decreased from 22 days in 2009 to 12 days in 2014, and the proportion of patients treated within the 14-day interval increased from 37% to 58%. Similarly, data from Germany from 2003 to 2014 showed that the interval from the ischemic event to receiving CEA decreased from 28 days to 8 days. Despite this, in China, the proportion of patients who received carotid revascularization within 14 days is still relatively low due to concerns about increased perioperative complications of acute revascularization.
Previously, the investigators retrospectively analyzed 1172 patients with symptomatic carotid stenosis, and used diffusion-weighted imaging (DWI) and apparent diffusion coefficient (ADC) sequences to identify whether there was acute new infarction before surgery. Further analysis found that for patients with symptomatic carotid stenosis combined with acute new infarction, regardless of the type of revascularization (CEA or CAS), the risk of postoperative serious adverse events was significantly increased. Therefore, for patients with preoperative new infarction on MRI, the investigators urgently need more effective treatment strategies to reduce the incidence of postoperative adverse events and improve the long-term prognosis of patients. The discussion of the timing of surgery is an important part of the treatment strategy. However, there is no large-scale clinical study report on whether preoperative new infarction on MRI has an auxiliary effect on the optimal timing of surgery for symptomatic carotid artery stenosis. Therefore, the investigators plan to initiate a multicenter, prospective, randomized, open-label, blinded RCT trial to explore whether preoperative new infarction on MRI can serve as a new marker for the safety and effectiveness of revascularization surgery in patients with symptomatic carotid artery stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEA/CAS within 48 hours after randomization | Experimental | Procedure: CEA/CAS plus best medical treatmentAll 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. |
| CEA/CAS after 14 days of randomization | Other | Procedure: CEA/CAS plus best medical treatmentAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
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/CAS plus best medical treatmentTiming of CEA/CAS plus best medical treatment | Procedure or surgery | CEA/CAS after 14 days of randomization, CEA/CAS within 48 hours after randomization |
Primary outcome
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.
Time frame: From randomization to 3 months
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.
15 secondary outcomes
Ischemic stroke in the responsible vascular territory
Time frame: 30 days and 3 months post-randomization
Any stroke
Time frame: from randomization to 3 months post-randomization
Disabling stroke (mRS>3)
Time frame: from randomization to 3 months
Fatal stroke
Time frame: from randomization to 3months
Hemorrhagic stroke
Time frame: from randomization to 3 months
Death
Time frame: from randomization to 3 months
Any stroke, death, myocardial infarction
Time frame: from randomization to 3 months
Myocardial infarction
Time frame: from randomization to 3 months
Proportional distribution of mRS/NIHSS
Time frame: 3 months post-randomization
EQ-5D-5L
Time frame: 3 months post-randomization
Rehospitalization
Time frame: from randomization to 3 months
Ischemic stroke or urgent revascularization
Time frame: Randomization to surgery
Any stroke, death and myocardial infarction
Time frame: surgery to 30 days
Average hospital stay
Time frame: from randomization to 3 months
Average hospital cost
Time frame: from randomization to 3 months
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 10 Sep 2026.
- Background: 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.
- Background: PubMed 15043958Rothwell 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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEA/CAS plus best medical treatment in people with Carotid Endarterectomy and Carotid Stenting, run by Xuanwu Hospital, Beijing at 1 site in China.
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 7 inclusion and 15 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Yan Prof. Ma, MD (+86 15001376121, xrqssq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From randomization to 3 months). 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 NCT06898151, which also lists 2 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 10 Sep 2026.