Carotid Artery StenosisNCT07678164
A Randomized Trial of Carotid Artery Stenting With Balloon Guide Catheter
A study testing Balloon Guide Catheter and Filter in people with Carotid Artery Stenosis, run by Hebei General Hospital.
Trial summary
This prospective, multicenter, randomized controlled study enrolled patients undergoing carotid artery stenting (CAS) with cerebral embolic protection for carotid artery stenosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Balloon Guide Catheter and Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years (inclusive), with no gender restriction.
- Imaging diagnosis indicates symptomatic carotid artery stenosis (by NASCET method) ≥50% or asymptomatic carotid artery stenosis (by NASCET method) ≥70%.
- Suitable for carotid artery stenting.
- Good compliance, voluntarily signed the informed consent form, and able to follow up as required.
Who cannot join
- Severe tortuosity or calcification of the diseased vessel, preventing device delivery.
- Patients with ipsilateral external carotid artery occlusion or severe stenosis of the intracranial segment of the internal carotid artery.
- Patients with contralateral common carotid artery occlusion or severe stenosis or occlusion of the internal carotid artery.
- Patients with severe stenosis or occlusion of the vertebrobasilar artery (excluding non-dominant vertebral artery).
- Spontaneous intracranial hemorrhage, massive cerebral infarction, progressive stroke, or myocardial infarction within the past 3 months.
- Presence of substantial acute or subacute thrombus adjacent to the lesion.
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- mRS > 3.
- Patients with a clear risk of cardioembolism, such as atrial fibrillation, or those with definite indications for anticoagulation.
- Chronic obstructive pulmonary disease requiring long-term continuous oxygen therapy.
- Patients with prior stent treatment in the ipsilateral head and neck vessels.
- Patients with end-stage renal failure requiring dialysis.
- Life expectancy less than 6 months.
- Patients unsuitable for magnetic resonance imaging (MRI) for any reason.
- Patients with absolute or relative contraindications to antiplatelet therapy.
- Inability to cooperate with the study due to dementia or mental disorder.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Balloon Guide Catheter-Assisted Carotid Artery Stenting With Multimodal Cerebral Protection: A Prospective, Multicenter, Randomized Controlled Trial
This prospective, multicenter, randomized controlled study enrolled patients undergoing carotid artery stenting (CAS) with cerebral embolic protection for carotid artery stenosis. They were randomly assigned to either a combination of proximal balloon occlusion, filter protection, intermediate catheter or filter protection alone. The study included 132 patients, and the primary endpoint was the number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure.
Read the detailed description
Carotid artery stenting (CAS) is an established treatment for carotid stenosis, yet the optimal cerebral embolic protection strategy remains uncertain. This prospective, multicenter, randomized, open-label, controlled trial will enroll 132 patients with symptomatic (≥50%) or asymptomatic (≥70%) carotid stenosis, who will be randomly assigned 1:1 to either experimental multimodal protection (Balloon Guide Catheter plus distal filter and intermediate catheter aspiration) or conventional distal filter protection alone. The primary endpoint is the number of new infarcts on post-procedural diffusion-weighted imaging (DWI) assessed within 48 hours (±24 hours), with secondary endpoints including device success and defect rates, incidences of symptomatic and all intracranial hemorrhage within 48 hours post-procedure, ipsilateral target-vessel stroke, TIA, major adverse events (stroke/death/MI), and adverse/serious adverse events at 30 and 90 days, all-cause mortality at 90 days, changes in mRS score at 30 and 90 days, and procedure-related complications (e.g., dissection, hyperperfusion syndrome).
- Conditions
- Carotid Artery Stenosis
- Being tested
- Balloon Guide Catheter, Filter
- Keywords
- balloon guide catheter
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon Guide CatheterDevice
Balloon guide catheter for proximal flow arrest and debris aspiration during carotid stenting.
FilterDevice
Distal embolic filter deployed beyond the stenosis to capture debris during stent placement.
| Study group | Role | What they receive |
|---|---|---|
| Combined Cerebral Protection (BGC + Filter + intermediate catheter) | Experimental | Participants in this arm will undergo carotid artery stenting (CAS) with a multimodal cerebral embolic protection strategy, incorporating proximal balloon occlusion via a Balloon Guide Catheter (BGC), distal filter protection, and active aspiration through an intermediate catheter. Receives: Device: Balloon Guide Catheter |
| Standard Protection Group (Filter Alone) | Active comparator | Participants in this arm will undergo carotid artery stenting (CAS) with distal filter protection. Receives: Device: Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure
Total number of new DWI positive lesions on post procedural brain MRI within 48 hours (±24 hours). New lesions are defined as foci of hyperintensity not seen on baseline DWI (if available), or otherwise as lesions consistent with acute embolic infarction.
Measured: within 48 hours (±24 hours) post-procedure
Secondary outcomes (11)
Device Success Rate
Device success for the balloon dilation catheter is defined as successful delivery, complete inflation, and smooth retrieval of the catheter system.
Measured: during the procedure
Incidence of Major Adverse Events (MAE) within 30 days, including any stroke, death, and myocardial infarction.
The rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke, or myocardial infarction within 30-day post-procedure.
Measured: within 30-day post-procedure
Changes in mRS score at 30 days and 90 days post-procedure.
Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death).
Measured: 30 days and 90 days post-procedure
Incidence of ipsilateral target vessel stroke at 30 days and 90 days post-procedure.
Stroke is defined as an acute neurological deficit of vascular origin lasting ≥24 hours, or lasting <24 hours with neuroimaging evidence of new infarction, occurring in the territory of the treated carotid artery.
Measured: 30 days and 90 days post-procedure
Incidence of transient ischemic attacks (TIA) at 30 days and 90 days post-procedure.
Transient ischemic attacks (TIA) was defined as transient focal neurological deficit of vascular origin lasting <24 hours with no acute infarct on neuroimaging.
Measured: 30 days and 90 days post-procedure
Incidence of Procedure-related complications (e.g., vessel dissection, hyperperfusion syndrome, etc.).
Procedure related complications include vessel dissection, hyperperfusion syndrome, access site events, and other adverse events directly attributable to carotid artery stenting (CAS).
Measured: during the procedure
Incidence of adverse events and serious adverse events at 30 days and 90 days post-procedure.
The Incidence of Adverse events or severe adverse event at 30 days and 90 days post-procedure.
Measured: 30 days and 90 days post-procedure
Incidence of symptomatic intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
Symptomatic intracranial hemorrhage defined as any intracranial hemorrhage on imaging with new neurological symptoms or NIHSS increase ≥4, or death.
Measured: within 48 hours (±24 hours) post-procedure
Incidence of intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
Incidence of all intracranial hemorrhage on post-procedural brain imaging within 48 hours.
Measured: within 48 hours (±24 hours) post-procedure
Incidence of all-cause mortality within 90 days post-procedure.
Incidence of death from any cause occurring within 90 days following the procedure.
Measured: 90 days post-procedure
Incidence of device defects.
The Incidence of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies 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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GuoQiang Xu, Hebei General Hospital
- Investigators
- Guodong Xu, Principal investigator, Hebei General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678164
- Sponsor's protocol ID
- BGC-2026-01
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Guide Catheter-Assisted Carotid Artery Stenting With Multimodal Cerebral Protection: A Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07678164
- Acronym / sponsor ID
- BGC-2026-01
- Conditions
- Carotid Artery Stenosis
- Keywords
- balloon guide catheter
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Hebei General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Jul 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 prospective, multicenter, randomized controlled study enrolled patients undergoing carotid artery stenting (CAS) with cerebral embolic protection for carotid artery stenosis. They were randomly assigned to either a combination of proximal balloon occlusion, filter protection, intermediate catheter or filter protection alone. The study included 132 patients, and the primary endpoint was the number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure.
Detailed description
Carotid artery stenting (CAS) is an established treatment for carotid stenosis, yet the optimal cerebral embolic protection strategy remains uncertain. This prospective, multicenter, randomized, open-label, controlled trial will enroll 132 patients with symptomatic (≥50%) or asymptomatic (≥70%) carotid stenosis, who will be randomly assigned 1:1 to either experimental multimodal protection (Balloon Guide Catheter plus distal filter and intermediate catheter aspiration) or conventional distal filter protection alone. The primary endpoint is the number of new infarcts on post-procedural diffusion-weighted imaging (DWI) assessed within 48 hours (±24 hours), with secondary endpoints including device success and defect rates, incidences of symptomatic and all intracranial hemorrhage within 48 hours post-procedure, ipsilateral target-vessel stroke, TIA, major adverse events (stroke/death/MI), and adverse/serious adverse events at 30 and 90 days, all-cause mortality at 90 days, changes in mRS score at 30 and 90 days, and procedure-related complications (e.g., dissection, hyperperfusion syndrome).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Cerebral Protection (BGC + Filter + intermediate catheter) | Experimental | Device: Balloon Guide CatheterParticipants in this arm will undergo carotid artery stenting (CAS) with a multimodal cerebral embolic protection strategy, incorporating proximal balloon occlusion via a Balloon Guide Catheter (BGC), distal filter protection, and active aspiration through an intermediate catheter. |
| Standard Protection Group (Filter Alone) | Active comparator | Device: FilterParticipants in this arm will undergo carotid artery stenting (CAS) with distal filter protection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 80 years (inclusive), with no gender restriction.
- Imaging diagnosis indicates symptomatic carotid artery stenosis (by NASCET method) ≥50% or asymptomatic carotid artery stenosis (by NASCET method) ≥70%.
- Suitable for carotid artery stenting.
- Good compliance, voluntarily signed the informed consent form, and able to follow up as required.
Key exclusion criteria (15 listed)
- Severe tortuosity or calcification of the diseased vessel, preventing device delivery.
- Patients with ipsilateral external carotid artery occlusion or severe stenosis of the intracranial segment of the internal carotid artery.
- Patients with contralateral common carotid artery occlusion or severe stenosis or occlusion of the internal carotid artery.
- Patients with severe stenosis or occlusion of the vertebrobasilar artery (excluding non-dominant vertebral artery).
- Spontaneous intracranial hemorrhage, massive cerebral infarction, progressive stroke, or myocardial infarction within the past 3 months.
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 |
|---|---|---|
| Balloon Guide CatheterBalloon guide catheter for proximal flow arrest and debris aspiration during carotid stenting. | Device | Combined Cerebral Protection (BGC + Filter + intermediate catheter) |
| FilterDistal embolic filter deployed beyond the stenosis to capture debris during stent placement. | Device | Standard Protection Group (Filter Alone) |
Primary outcome
Number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure
Time frame: within 48 hours (±24 hours) post-procedure
Total number of new DWI positive lesions on post procedural brain MRI within 48 hours (±24 hours). New lesions are defined as foci of hyperintensity not seen on baseline DWI (if available), or otherwise as lesions consistent with acute embolic infarction.
11 secondary outcomes
Device Success Rate
Time frame: during the procedure
Incidence of Major Adverse Events (MAE) within 30 days, including any stroke, death, and myocardial infarction.
Time frame: within 30-day post-procedure
Changes in mRS score at 30 days and 90 days post-procedure.
Time frame: 30 days and 90 days post-procedure
Incidence of ipsilateral target vessel stroke at 30 days and 90 days post-procedure.
Time frame: 30 days and 90 days post-procedure
Incidence of transient ischemic attacks (TIA) at 30 days and 90 days post-procedure.
Time frame: 30 days and 90 days post-procedure
Incidence of Procedure-related complications (e.g., vessel dissection, hyperperfusion syndrome, etc.).
Time frame: during the procedure
Incidence of adverse events and serious adverse events at 30 days and 90 days post-procedure.
Time frame: 30 days and 90 days post-procedure
Incidence of symptomatic intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
Time frame: within 48 hours (±24 hours) post-procedure
Incidence of intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
Time frame: within 48 hours (±24 hours) post-procedure
Incidence of all-cause mortality within 90 days post-procedure.
Time frame: 90 days post-procedure
Incidence of device defects.
Time frame: during the procedure
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 1 Jul 2026.
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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.
Guodong Xu principal investigator
Hebei General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Balloon Guide Catheter and Filter in people with Carotid Artery Stenosis, run by Hebei General Hospital.
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 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: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Zhao (185 0327 2089, zhaoyan2333@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure (time frame: within 48 hours (±24 hours) post-procedure). 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 1 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.