Carotid Endarterectomy and Stenting Timing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.);
Trial design
Design model
Parallel
Treatments tested in this trial
CEA/CAS plus best medical treatment
Procedure/SurgeryTiming of CEA/CAS plus best medical treatment
Treatment groups
268 Participants
are divided into 2 treatment groupsGroup A: CEA/CAS within 48 hours after randomizationExperimental treatment 1 intervention
Group B: CEA/CAS after 14 days of randomizationOther 1 intervention
Trial outcomes
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.
Time frame
From randomization to 3 monthsSecondary outcomes
1
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.
Time frame
30 days and 3 months post-randomization2
Any stroke
The ischemic or hemorrhagic stroke will be confirmed by cerebral MRI or CT.
Time frame
from randomization to 3 months post-randomization3
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.
Time frame
from randomization to 3 months4
Fatal stroke
Ischemic or hemorrhagic stroke (confirmed on cerebral MRI) leading to death.
Time frame
from randomization to 3monthsSponsors and contacts
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Source ClinicalTrials.gov