Carotid Artery Stenosis (Symptomatic and Asymptomatic)CEST-PROTECTNCT07841132
CEST-PROTECT: Proximal Flow Control With a Balloon Guide Catheter Plus Distal Embolic Protection: a Randomised, Open-label Trial Evaluating Cerebral Protection Techniques
A study testing Single distal filter embolic protection device during carotid artery stenting in people with Carotid Artery Stenosis (Symptomatic and Asymptomatic), run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Artery Stenosis (Symptomatic and Asymptomatic)
- What is being tested?
- Single distal filter embolic protection device during carotid artery stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to May 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years, regardless of sex.
- Symptomatic carotid artery stenosis ≥50% or asymptomatic carotid artery stenosis ≥70%, with the degree of stenosis determined according to the prespecified NASCET method and confirmed by CTA, DSA, or MRA.
- Presence of at least one protocol-defined complex high-risk carotid stenosis feature confirmed by carotid ultrasonography, CTA, DSA, HR-VWI, or other protocol-specified imaging modalities.
- Written informed consent provided by the participant or legally authorized representative.
Who cannot join
- Other cerebrovascular lesions that may substantially increase peri-procedural risk or interfere with assessment of the primary outcome, including an untreated ipsilateral intracranial aneurysm >5 mm, cerebral arteriovenous malformation, dural arteriovenous fistula, or other vascular lesions considered to pose significant risk by multidisciplinary assessment.
- Severe ipsilateral intracranial tandem stenosis ≥70% that is related to a recent ischemic event, is planned for intervention during the study follow-up period, or may interfere with attribution of post-procedural stroke; or complete occlusion of the contralateral internal carotid artery with an unacceptable risk of intolerance to proximal flow arrest.
- Technical conditions precluding carotid artery stenting or preventing safe implementation of either randomized cerebral protection strategy, including target-vessel occlusion or near-occlusion with distal collapse; free-floating thrombus or high-burden active intraluminal thrombus; absence of an appropriate landing zone for the distal embolic protection device or balloon flow-control segment in the common carotid artery; inability to safely cross, deploy, or retrieve the distal protection device; inability to safely and stably position the balloon guide catheter; severe aortic arch, supra-aortic, carotid-origin, or iliofemoral disease resulting in unacceptable transfemoral access risk; severe vascular tortuosity, angulation, or calcification resulting in unacceptable device-passage, vascular-injury, or stent-deployment risk; unacceptable risk of intolerance to proximal flow arrest; or any other condition preventing safe implementation of either randomized strategy.
- Previous stenting, angioplasty, or other endovascular mechanical treatment of the target carotid artery; or carotid lesions not prespecified for inclusion in the etiologic complex-lesion cohort, including carotid dissection, vasculitis, traumatic or infectious lesions, pseudoaneurysm, or fibromuscular dysplasia other than carotid web.
- Modified Rankin Scale (mRS) score ≥3 after a recent stroke, or the presence of a large cerebral infarction, significant cerebral edema or mass effect, hemorrhagic transformation, impaired consciousness, progressive neurological deficits, or clinically unstable neurological status.
- Contraindication to contrast agents, antiplatelet therapy, anticoagulant therapy, or medications required during the procedure that cannot be adequately managed; or inability or expected inability to receive or complete protocol-required dual antiplatelet therapy.
Show all 12Show fewer
- A recent ischemic event considered primarily cardioembolic, or the presence of a high-risk cardiac source of embolism such as left atrial or left ventricular thrombus, infective endocarditis, a mechanical heart valve with inadequate anticoagulation, or an intracardiac mass. Atrial fibrillation alone is not an absolute exclusion criterion unless it is considered the primary cause of the qualifying ischemic event or required anticoagulation cannot be safely combined with the protocol-required antiplatelet regimen.
- A serious medical condition precluding elective carotid artery stenting, including active bleeding, uncorrectable coagulopathy, severe renal dysfunction without adequate risk-control measures, persistent uncontrolled severe hypertension, active severe infection, myocardial infarction within 6 weeks before screening, unstable acute coronary syndrome, decompensated heart failure, uncontrolled severe arrhythmia, or another serious systemic disease.
- Contraindication to MRI or anticipated inability to complete the protocol-required baseline and post-procedural MRI/DWI examinations.
- Current participation, or participation within 3 months before screening, in another clinical study that may affect the study intervention, safety assessment, or primary outcome evaluation; or planned major surgery or endovascular treatment during the peri-procedural period or 30-day follow-up that may interfere with assessment of study outcomes.
- Inability to understand or comply with study procedures, provide valid informed consent, complete the 30-day clinical follow-up or neurological assessments, or provide reliable primary outcome data; or life expectancy shorter than the required study follow-up period.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study, substantially increases study-related risk, or may compromise the reliability of the study results.
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
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Jichang Luo, MD, +86 13120136577, luojichang_dr@sina.com
About this study
Official title: Balloon Guide Catheter-Mediated Proximal Flow Control Plus Distal Embolic Protection Versus Distal Embolic Protection Alone During Carotid Artery Stenting in Patients With Complex High-Risk Carotid Stenosis-A Multicentre, Randomised, Open-Label, Blinded Trial
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.
Read the detailed description
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.
- Being tested
- BGC proximal flow control plus distal filter embolic protection device during carotid artery stenting, Single distal filter embolic protection device during carotid artery stenting
- Keywords
- Carotid artery stenting, Embolic protection device, Proximal protection, Distal protection, Carotid artery stenosis, New cerebral infarction, Diffusion-weighted imaging, stroke
- Medical subject headings
- Carotid Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGC proximal flow control plus distal filter embolic protection device during carotid artery stentingProcedure or surgery
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.
Single distal filter embolic protection device during carotid artery stentingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| BGC proximal flow control plus distal filter embolic protection device | Experimental | 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 Receives: Procedure: BGC proximal flow control plus distal filter embolic protection device during carotid artery stenting |
| Single distal filter embolic protection device | Active comparator | 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. Receives: Procedure: Single distal filter embolic protection device during carotid artery stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 72 hours after carotid artery stenting
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 30 (±7) days after carotid artery stenting
Incidence of Ipsilateral Ischemic Stroke
The incidences of ipsilateral ischemic stroke will be assessed individually.
Measured: Within 7 (±2) and 30 (±7) days after carotid artery stenting
Incidence of Ipsilateral TIA
The incidences of ipsilateral TIA will be assessed individually.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 30 (±7) days after carotid artery stenting
Incidence of Intracranial Hemorrhage
The proportion of participants experiencing any intracranial hemorrhage after carotid artery stenting.
Measured: 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.
Measured: 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.
Measured: Within 30 (±7) days after carotid artery stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery Stenosis (Symptomatic and Asymptomatic)Studies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Union hospital of Fujian Medical University, Fujian Zhangzhou hospital, People's Hospital of Gaomi City, The First Affiliated Hospital of Haerbin Medical University, Henan Provincial People's Hospital, Heze Municipal Hospital, Jiangsu Provincial People's Hospital, Linyi People's Hospital, The First People's Hospital of Mianyang, Nanyang Central Hospital, Shandong Provincial Hospital, Shanxi Cardiovascular Hospital, Jinan Hospital, Xuanwu Hospital, Capital Medical University, Tianjin Huanhu Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital, Xinqiao Hospital, Baoji third people's hospital, Liaocheng People's Hospital, Liaocheng Brains Hospital / Liaocheng People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841132
- Sponsor's protocol ID
- CEST-PROTECT
- Acronym
- CEST-PROTECT
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Guide Catheter-Mediated Proximal Flow Control Plus Distal Embolic Protection Versus Distal Embolic Protection Alone During Carotid Artery Stenting in Patients With Complex High-Risk Carotid Stenosis-A Multicentre, Randomised, Open-Label, Blinded Trial
- ClinicalTrials.gov ID
- NCT07841132
- Acronym / sponsor ID
- CEST-PROTECT / CEST-PROTECT
- Keywords
- Carotid artery stenting, Embolic protection device, Proximal protection, Distal protection, Carotid artery stenosis, New cerebral infarction, Diffusion-weighted imaging, stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Union hospital of Fujian Medical University, Fujian Zhangzhou hospital, People's Hospital of Gaomi City, The First Affiliated Hospital of Haerbin Medical University, Henan Provincial People's Hospital, Heze Municipal Hospital, Jiangsu Provincial People's Hospital, Linyi People's Hospital, The First People's Hospital of Mianyang, Nanyang Central Hospital, Shandong Provincial Hospital, Shanxi Cardiovascular Hospital, Jinan Hospital, Xuanwu Hospital, Capital Medical University, Tianjin Huanhu Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital, Xinqiao Hospital, Baoji third people's hospital, Liaocheng People's Hospital, Liaocheng Brains Hospital / Liaocheng People's Hospital
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 25 Sep 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BGC proximal flow control plus distal filter embolic protection device | Experimental | Procedure: BGC proximal flow control plus distal filter embolic protection device during carotid artery stentingCarotid 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 |
| Single distal filter embolic protection device | Active comparator | Procedure: Single distal filter embolic protection device during carotid artery stentingCarotid 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 80 years, regardless of sex.
- Symptomatic carotid artery stenosis ≥50% or asymptomatic carotid artery stenosis ≥70%, with the degree of stenosis determined according to the prespecified NASCET method and confirmed by CTA, DSA, or MRA.
- Presence of at least one protocol-defined complex high-risk carotid stenosis feature confirmed by carotid ultrasonography, CTA, DSA, HR-VWI, or other protocol-specified imaging modalities.
- Written informed consent provided by the participant or legally authorized representative.
Key exclusion criteria (12 listed)
- Other cerebrovascular lesions that may substantially increase peri-procedural risk or interfere with assessment of the primary outcome, including an untreated ipsilateral intracranial aneurysm >5 mm, cerebral arteriovenous malformation, dural arteriovenous fistula, or other vascular lesions considered to pose significant risk by multidisciplinary assessment.
- Severe ipsilateral intracranial tandem stenosis ≥70% that is related to a recent ischemic event, is planned for intervention during the study follow-up period, or may interfere with attribution of post-procedural stroke; or complete occlusion of the contralateral internal carotid artery with an unacceptable risk of intolerance to proximal flow arrest.
- Technical conditions precluding carotid artery stenting or preventing safe implementation of either randomized cerebral protection strategy, including target-vessel occlusion or near-occlusion with distal collapse; free-floating thrombus or high-burden active intraluminal thrombus; absence of an appropriate landing zone for the distal embolic protection device or balloon flow-control segment in the common carotid artery; inability to safely cross, deploy, or retrieve the distal protection device; inability to safely and stably position the balloon guide catheter; severe aortic arch, supra-aortic, carotid-origin, or iliofemoral disease resulting in unacceptable transfemoral access risk; severe vascular tortuosity, angulation, or calcification resulting in unacceptable device-passage, vascular-injury, or stent-deployment risk; unacceptable risk of intolerance to proximal flow arrest; or any other condition preventing safe implementation of either randomized strategy.
- Previous stenting, angioplasty, or other endovascular mechanical treatment of the target carotid artery; or carotid lesions not prespecified for inclusion in the etiologic complex-lesion cohort, including carotid dissection, vasculitis, traumatic or infectious lesions, pseudoaneurysm, or fibromuscular dysplasia other than carotid web.
- Modified Rankin Scale (mRS) score ≥3 after a recent stroke, or the presence of a large cerebral infarction, significant cerebral edema or mass effect, hemorrhagic transformation, impaired consciousness, progressive neurological deficits, or clinically unstable neurological status.
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 |
|---|---|---|
| BGC proximal flow control plus distal filter embolic protection device during carotid artery stentingCarotid 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. | Procedure or surgery | BGC proximal flow control plus distal filter embolic protection device |
| Single distal filter embolic protection device during carotid artery stentingCarotid 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 | Procedure or surgery | Single distal filter embolic protection device |
Primary outcome
Proportion of Participants With at Least One New Ipsilateral Cerebral Ischemic Lesion on Diffusion-Weighted MRI
Time frame: Within 72 hours after carotid artery stenting
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.
12 secondary outcomes
Composite of Any Stroke or All-Cause Death Within 30 Days
Time frame: Within 30 (±7) days after carotid artery stenting
Number and Distribution of New Cerebral Ischemic Lesions on Diffusion-Weighted MRI
Time frame: Within 72 hours after carotid artery stenting
Characteristics of New Cerebral Ischemic Lesions on Diffusion-Weighted MRI
Time frame: Within 72 hours after carotid artery stenting
Proportion of Participants With New Symptomatic or Asymptomatic Cerebral Infarction
Time frame: Within 30 (±7) days after carotid artery stenting
Incidence of Ipsilateral Ischemic Stroke
Time frame: Within 7 (±2) and 30 (±7) days after carotid artery stenting
Incidence of Ipsilateral TIA
Time frame: Within 7 (±2) and 30 (±7) days after carotid artery stenting
Incidence of All-cause Death
Time frame: Within 7 (±2) and 30 (±7) days after carotid artery stenting
NIHSS Score and Change From Baseline
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
Time frame: At 30 (±7) days after carotid artery stenting
Incidence of Intracranial Hemorrhage
Time frame: Within 72 hours after carotid artery stenting
Incidence of Adverse Events and Serious Adverse Events
Time frame: Within 30 (±7) days after carotid artery stenting
Incidence of Device- or Procedure-Related Adverse Events
Time frame: Within 30 (±7) days after carotid artery stenting
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 25 Sep 2026.
- Individual participant dataSharing planned: No. Deidentified individual participant data will not be shared.
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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 Single distal filter embolic protection device during carotid artery stenting in people with Carotid Artery Stenosis (Symptomatic and Asymptomatic), 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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 25 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 Jichang Luo, MD. (+86 13120136577, luojichang_dr@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With at Least One New Ipsilateral Cerebral Ischemic Lesion on Diffusion-Weighted MRI (time frame: Within 72 hours after carotid artery stenting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.