An interventional study of BGC proximal flow control plus distal filter embolic protection device during carotid artery stenting and Single distal filter embolic protection device during carotid artery stenting in Carotid Artery Stenosis (Symptomatic and Asymptomatic), sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
This randomized controlled trial aims to evaluate whether a proximal-distal dual cerebral protection strategy can reduce the occurrence of new cerebral ischemic lesions compared with a single cerebral protection strategy in patients undergoing carotid artery stenting. Eligible participants will be randomly assigned to receive either dual cerebral protection using proximal flow control combined with a distal embolic protection device or conventional single cerebral protection. Brain magnetic resonance imaging will be performed after the procedure to assess new ischemic lesions. The study will also evaluate peri-procedural neurological events and other safety and efficacy outcomes.
Carotid artery stenting is an established treatment for selected patients with carotid artery stenosis, but peri-procedural cerebral embolization remains an important concern. Distal embolic protection devices are commonly used during carotid artery stenting; however, embolization may occur during lesion crossing or device manipulation before complete distal protection is established.
The CEST-PROTECT trial is a prospective, multicenter, randomized controlled study designed to investigate whether a proximal-distal dual cerebral protection strategy provides additional cerebral protection compared with a conventional single protection strategy during carotid artery stenting. Participants will be randomly assigned to the dual-protection group or the single-protection group.
In the dual-protection group, proximal flow control will be combined with a distal embolic protection device during carotid artery stenting. In the single-protection group, carotid artery stenting will be performed using conventional distal embolic protection alone.
Brain magnetic resonance imaging, including diffusion-weighted imaging, will be performed after the procedure to identify new cerebral ischemic lesions. Clinical neurological outcomes, procedural outcomes, and safety events will also be assessed during follow-up. The study is intended to determine whether the dual-protection strategy can reduce peri-procedural cerebral embolic injury without increasing procedure-related complications.
364 studies on the registry are indexed under Carotid Stenosis; 85 are open to participants now.
This study's planned enrollment of 500 is above the median of 103 across 189 interventional studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Carotid artery stenting will be performed via a transfemoral approach. Proximal flow control will be established using a balloon guide catheter (BGC) and combined with a distal filter embolic protection device, allowing the procedure to be performed under dual proximal and distal cerebral protection
Procedure: BGC proximal flow control plus distal filter embolic protection device during carotid artery stenting
Carotid artery stenting will be performed according to a standardized procedure under the protection of a distal embolic protection device. The selection criteria for the distal protection device and stent will be consistent with those used in the experimental group. The brand, model, size, rationale for selection, and details of device use will be fully documented.
Procedure: Single distal filter embolic protection device during carotid artery stenting
Carotid artery stenting will be performed via a transfemoral approach. Proximal flow control will be established using a balloon guide catheter (BGC) and combined with a distal filter embolic protection device. Carotid artery stenting will then be completed under dual proximal and distal cerebral protection.
Carotid artery stenting will be performed according to a standardized procedure under the protection of a distal embolic protection device. The selection criteria for the distal protection device and stent will be consistent with those used in the experimental group. The brand, model, size, rationale for selection, and details of device use will be fully
Proportion of Participants With at Least One New Ipsilateral Cerebral Ischemic Lesion on Diffusion-Weighted MRI
The primary outcome is the proportion of participants with at least one new cerebral ischemic lesion on the side of the target carotid artery detected by diffusion-weighted magnetic resonance imaging (DWI) after carotid artery stenting, compared with the pre-procedural baseline MRI. New ischemic lesions will be assessed by an independent central imaging core laboratory blinded to treatment allocation.
Time frame: Within 72 hours after carotid artery stenting
Composite of Any Stroke or All-Cause Death Within 30 Days
First occurrence of any stroke or all-cause death within 30 days after carotid artery stenting. Clinical events will be adjudicated by an independent Clinical Events Committee blinded to treatment allocation.
Time frame: Within 30 (±7) days after carotid artery stenting
Number and Distribution of New Cerebral Ischemic Lesions on Diffusion-Weighted MRI
The number and distribution of new cerebral ischemic lesions detected on post-procedural diffusion-weighted MRI compared with the pre-procedural baseline MRI. Distribution of new ischemic lesions according to laterality (ipsilateral or contralateral to the target carotid artery) and vascular territory involvement (single or multiple vascular territories). Lesions will be assessed by an independent central imaging core laboratory blinded to treatment allocation.
Time frame: Within 72 hours after carotid artery stenting
Characteristics of New Cerebral Ischemic Lesions on Diffusion-Weighted MRI
New cerebral ischemic lesions will be classified as cortical or subcortical. Lesions will also be categorized according to the maximum lesion diameter.
Time frame: Within 72 hours after carotid artery stenting
Proportion of Participants With New Symptomatic or Asymptomatic Cerebral Infarction
The proportions of participants with newly developed symptomatic cerebral infarction and newly developed asymptomatic cerebral infarction after carotid artery stenting will be assessed separately. Symptomatic cerebral infarction is defined as a new cerebral infarction associated with corresponding new neurological symptoms, whereas asymptomatic cerebral infarction is defined as a new cerebral infarction without corresponding new neurological symptoms.
Time frame: Within 30 (±7) days after carotid artery stenting
Incidence of Ipsilateral Ischemic Stroke
The incidences of ipsilateral ischemic stroke will be assessed individually.
Time frame: Within 7 (±2) and 30 (±7) days after carotid artery stenting
Incidence of Ipsilateral TIA
The incidences of ipsilateral TIA will be assessed individually.
Time frame: Within 7 (±2) and 30 (±7) days after carotid artery stenting
Incidence of All-cause Death
The incidences of all-cause death will be assessed individually.
Time frame: Within 7 (±2) and 30 (±7) days after carotid artery stenting
NIHSS Score and Change From Baseline
Neurological impairment will be assessed using the National Institutes of Health Stroke Scale (NIHSS). The NIHSS score and its change from the pre-procedural baseline will be evaluated at 7 days or hospital discharge and again at 30 days after carotid artery stenting.
Time frame: At 7 (±2) days or hospital discharge, whichever occurs first, and at 30 (±7) days after carotid artery stenting
Modified Rankin Scale Score and Change From Baseline
Functional status will be assessed using the modified Rankin Scale (mRS). The mRS score and its change from the pre-procedural baseline will be evaluated at 30 days after carotid artery stenting.
Time frame: At 30 (±7) days after carotid artery stenting
Incidence of Intracranial Hemorrhage
The proportion of participants experiencing any intracranial hemorrhage after carotid artery stenting.
Time frame: Within 72 hours after carotid artery stenting
Incidence of Adverse Events and Serious Adverse Events
The proportion of participants experiencing any adverse event (AE) or serious adverse event (SAE) after carotid artery stenting.
Time frame: Within 30 (±7) days after carotid artery stenting
Incidence of Device- or Procedure-Related Adverse Events
The proportion of participants experiencing adverse events or serious adverse events considered related to the study device or study procedure.
Time frame: Within 30 (±7) days after carotid artery stenting
Plan to share: No — Deidentified individual participant data will not be shared.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2029, 30 months later.
Of 50 non-industry interventional studies with no phase under Carotid Stenosis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's planned 30 months is close to that.
Counting every sponsor, half of 61 studies reached it within 27 months; a quarter within 19 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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