Carotid Artery StenosisANGEL-BEACONNCT07247864
Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting
A study testing Balloon Guide Catheter and Distal Filter Protection Device in people with Carotid Artery Stenosis, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
This multicenter, randomized, controlled trial evaluates a combined embolic protection strategy during carotid artery stenting (CAS). Carotid artery stenosis is a major cause of stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Balloon Guide Catheter and Distal Filter Protection Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2025to 1 Dec 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 or older;
- Symptomatic extracranial carotid artery stenosis (occurrence of transient ischemic attack or non-disabling stroke in the ipsilateral carotid territory within the previous 6 months, with stenosis of 50% or greater) or asymptomatic extracranial carotid artery stenosis (stenosis of 70% or greater) meeting the indications for interventional treatment (stenosis degree measured by the NASCET method);
- Pre-treatment modified Rankin Scale (mRS) score of 0 to 1;
- Planned for stent treatment by the clinical care team;
- Informed consent obtained from the patient or their legally authorized representative.
Who cannot join
- Occlusion or severe stenosis (70% or greater) of the intracranial segment of the ipsilateral internal carotid artery system;
- Occlusion or severe stenosis (70% or greater) of the contralateral common carotid artery or internal carotid artery;
- History of stenting in the head and neck vessels within 3 months;
- Coexisting other cerebrovascular diseases, such as intracranial aneurysms greater than 5 mm or cerebrovascular malformations;
- Onset of stroke within 7 days;
- Large old infarctions from previous stroke that may confound the evaluation of endpoints;
Show all 14Show fewer
- Contraindications to magnetic resonance imaging (MRI);
- Definite risk of cardiogenic embolism (e.g., atrial fibrillation, atrial flutter, intracardiac thrombus) or clear indications for anticoagulation therapy;
- Absolute or relative contraindications to antiplatelet therapy;
- Pregnant or lactating women;
- Allergy or hypersensitivity to contrast media or stent materials (e.g., Nitinol);
- Life expectancy less than 1 year;
- Pre-existing neurological or psychiatric disorders (e.g., severe dementia) that would confound neurological assessments;
- Severe renal insufficiency (eGFR less than 30 mL/min).
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
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 101118
Xiaochuan Huo, Doctor, +86 13716292262, hxc810909@163.com
Xin Tong, Doctor, +86 17810651085, tomice123@foxmail.com
About this study
Official title: A Comparative Study of Carotid Artery Stenosis Stenting With Balloon Guide Catheter Combined With Distal Filter Versus Distal Filter Alone-A Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study
This multicenter, randomized, controlled trial evaluates a combined embolic protection strategy during carotid artery stenting (CAS). Carotid artery stenosis is a major cause of stroke. While stenting is an effective treatment, the procedure itself carries a risk of dislodging plaque debris, which can travel to the brain and cause new strokes or silent brain infarctions.
Currently, a distal filter (protection device) is standardly used to catch debris. However, it may not capture all particles. This study investigates whether adding a Balloon Guide Catheter (BGC)-which temporarily stops blood flow and allows for aspiration-to the standard filter protection is more effective than using the filter alone.
Read more
Patients with symptomatic (≥50% stenosis) or asymptomatic (≥70% stenosis) carotid artery stenosis who are scheduled for stenting will be randomly assigned to one of two groups:
- Combined Protection Group: Receiving CAS using a Balloon Guide Catheter combined with a distal filter.
- Standard Protection Group: Receiving CAS using a distal filter alone. The primary goal is to determine if the combined approach reduces the number of new ischemic lesions detected on brain MRI within 72 hours post-procedure. The study will also assess clinical stroke events over a 90-day follow-up period.
Read the detailed description
Pre-specified subgroup analyses will be conducted based on baseline symptom status (symptomatic vs. asymptomatic carotid artery stenosis) and stent design (open-cell vs. closed-cell).
- Conditions
- Carotid Artery Stenosis
- Being tested
- Balloon Guide Catheter, Distal Filter Protection Device
- Keywords
- Carotid artery stenosis, Carotid Artery Stenting, Balloon Guide Catheter, Embolic Protection Device, New Ischemic Lesions
- 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
Also called BGC
A catheter with a balloon at the distal tip, used to temporarily arrest flow and aspirate debris during the stenting procedure.
Distal Filter Protection DeviceDevice
Also called Embolic Protection Device, EPD
A mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Combined Protection Group (BGC + Filter) | Experimental | Patients in this group will undergo carotid artery stenting (CAS) using a Balloon Guide Catheter (BGC) for proximal protection combined with a distal filter protection device. Receives: Device: Balloon Guide Catheter; Device: Distal Filter Protection Device |
| Standard Protection Group (Filter Alone) | Active comparator | Patients in this group will undergo carotid artery stenting (CAS) using a standard guiding catheter and a distal filter protection device alone. Receives: Device: Distal Filter Protection Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of New Ischemic Lesions on Diffusion-Weighted Imaging (DWI)
Assessed by brain MRI (DWI sequences) performed within 72 hours post-procedure. The outcome is defined as the total number of new high-signal intensity lesions observed on the post-procedural DWI compared to pre-procedural baseline (if available) or recognized as new procedural emboli.
Measured: Post-procedure 72 hours (plus or minus 12 hours)
Secondary outcomes (15)
Procedural Success Rate
Defined as the successful deployment and retrieval of the stent and protection devices (Balloon Guide Catheter and/or Distal Filter) without technical failure.
Measured: Intra-operative
Total Volume of New Ischemic Lesions on DWI
The total volume (in milliliters) of new ischemic lesions measured on DWI MRI.
Measured: Post-procedure 72 hours (± 12 hours)
Incidence of New Symptomatic Ischemic Stroke
Occurrence of a new ischemic stroke presenting with clinical symptoms.
Measured: Post-procedure 72 hours (± 12 hours)
Rate of Early Neurological Deterioration (NIHSS Worsening)
Defined as an increase in the National Institutes of Health Stroke Scale (NIHSS) score of > 2 points compared to baseline.
Measured: Post-procedure 72 hours (± 12 hours)
All-Cause Mortality at 30 Days
Measured: 30 days (± 5 days)
Rate of Excellent Functional Outcome (mRS 0-1) at 30 Days
Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 1
Measured: 30 days (± 5 days)
Rate of Functional Independence (mRS 0-2) at 30 Days
Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 2.
Measured: 30 days (± 5 days)
Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 30 Days
The EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels. The responses are converted into a single utility index score (ranging from less than 0 to 1, where 1 indicates full health and 0 indicates dead). Higher scores indicate better health-related quality of life.
Measured: 30 days (± 5 days)
Rate of Excellent Functional Outcome (mRS 0-1) at 90 Days
Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 1.
Measured: 90 days (± 7 days)
Rate of Functional Independence (mRS 0-2) at 90 Days
Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 2.
Measured: 90 days (± 7 days)
Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 90 Days
The EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels. The responses are converted into a single utility index score (ranging from less than 0 to 1, where 1 indicates full health and 0 indicates dead). Higher scores indicate better health-related quality of life.
Measured: 90 days (± 7 days)
Incidence of Symptomatic Intracranial Hemorrhage
Measured: Post-procedure 72 hours (± 12 hours)
Incidence of Any Intracranial Hemorrhage
Measured: Post-procedure 72 hours (± 12 hours)
Incidence of Adverse Events (AEs)
Number of participants with adverse events.
Measured: Through study completion, up to 90 days
Incidence of Serious Adverse Events (SAEs)
Number of participants with serious adverse events.
Measured: Through study completion, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start3 Dec 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 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.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaochuan Huo, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247864
- Sponsor's protocol ID
- KS2025109
- Acronym
- ANGEL-BEACON
- Status last verified
- Sep 2026
- First submitted
- 18 Nov 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Carotid Artery Stenosis Stenting With Balloon Guide Catheter Combined With Distal Filter Versus Distal Filter Alone-A Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07247864
- Acronym / sponsor ID
- ANGEL-BEACON / KS2025109
- Conditions
- Carotid Artery Stenosis
- Keywords
- Carotid artery stenosis, Carotid Artery Stenting, Balloon Guide Catheter, Embolic Protection Device, New Ischemic Lesions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 25 Nov 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.
This multicenter, randomized, controlled trial evaluates a combined embolic protection strategy during carotid artery stenting (CAS). Carotid artery stenosis is a major cause of stroke. While stenting is an effective treatment, the procedure itself carries a risk of dislodging plaque debris, which can travel to the brain and cause new strokes or silent brain infarctions.
Currently, a distal filter (protection device) is standardly used to catch debris. However, it may not capture all particles. This study investigates whether adding a Balloon Guide Catheter (BGC)-which temporarily stops blood flow and allows for aspiration-to the standard filter protection is more effective than using the filter alone.
Patients with symptomatic (≥50% stenosis) or asymptomatic (≥70% stenosis) carotid artery stenosis who are scheduled for stenting will be randomly assigned to one of two groups:
- Combined Protection Group: Receiving CAS using a Balloon Guide Catheter combined with a distal filter.
- Standard Protection Group: Receiving CAS using a distal filter alone. The primary goal is to determine if the combined approach reduces the number of new ischemic lesions detected on brain MRI within 72 hours post-procedure. The study will also assess clinical stroke events over a 90-day follow-up period.
Detailed description
Pre-specified subgroup analyses will be conducted based on baseline symptom status (symptomatic vs. asymptomatic carotid artery stenosis) and stent design (open-cell vs. closed-cell).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Protection Group (BGC + Filter) | Experimental | Device: Balloon Guide Catheter, Device: Distal Filter Protection DevicePatients in this group will undergo carotid artery stenting (CAS) using a Balloon Guide Catheter (BGC) for proximal protection combined with a distal filter protection device. |
| Standard Protection Group (Filter Alone) | Active comparator | Device: Distal Filter Protection DevicePatients in this group will undergo carotid artery stenting (CAS) using a standard guiding catheter and a distal filter protection device alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older;
- Symptomatic extracranial carotid artery stenosis (occurrence of transient ischemic attack or non-disabling stroke in the ipsilateral carotid territory within the previous 6 months, with stenosis of 50% or greater) or asymptomatic extracranial carotid artery stenosis (stenosis of 70% or greater) meeting the indications for interventional treatment (stenosis degree measured by the NASCET method);
- Pre-treatment modified Rankin Scale (mRS) score of 0 to 1;
- Planned for stent treatment by the clinical care team;
- Informed consent obtained from the patient or their legally authorized representative.
Key exclusion criteria (14 listed)
- Occlusion or severe stenosis (70% or greater) of the intracranial segment of the ipsilateral internal carotid artery system;
- Occlusion or severe stenosis (70% or greater) of the contralateral common carotid artery or internal carotid artery;
- History of stenting in the head and neck vessels within 3 months;
- Coexisting other cerebrovascular diseases, such as intracranial aneurysms greater than 5 mm or cerebrovascular malformations;
- Onset of stroke within 7 days;
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 CatheterAlso: BGCA catheter with a balloon at the distal tip, used to temporarily arrest flow and aspirate debris during the stenting procedure. | Device | Combined Protection Group (BGC + Filter) |
| Distal Filter Protection DeviceAlso: Embolic Protection Device, EPDA mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure. | Device | Combined Protection Group (BGC + Filter), Standard Protection Group (Filter Alone) |
Primary outcome
Number of New Ischemic Lesions on Diffusion-Weighted Imaging (DWI)
Time frame: Post-procedure 72 hours (plus or minus 12 hours)
Assessed by brain MRI (DWI sequences) performed within 72 hours post-procedure. The outcome is defined as the total number of new high-signal intensity lesions observed on the post-procedural DWI compared to pre-procedural baseline (if available) or recognized as new procedural emboli.
15 secondary outcomes
Procedural Success Rate
Time frame: Intra-operative
Total Volume of New Ischemic Lesions on DWI
Time frame: Post-procedure 72 hours (± 12 hours)
Incidence of New Symptomatic Ischemic Stroke
Time frame: Post-procedure 72 hours (± 12 hours)
Rate of Early Neurological Deterioration (NIHSS Worsening)
Time frame: Post-procedure 72 hours (± 12 hours)
All-Cause Mortality at 30 Days
Time frame: 30 days (± 5 days)
Rate of Excellent Functional Outcome (mRS 0-1) at 30 Days
Time frame: 30 days (± 5 days)
Rate of Functional Independence (mRS 0-2) at 30 Days
Time frame: 30 days (± 5 days)
Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 30 Days
Time frame: 30 days (± 5 days)
Rate of Excellent Functional Outcome (mRS 0-1) at 90 Days
Time frame: 90 days (± 7 days)
Rate of Functional Independence (mRS 0-2) at 90 Days
Time frame: 90 days (± 7 days)
Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 90 Days
Time frame: 90 days (± 7 days)
Incidence of Symptomatic Intracranial Hemorrhage
Time frame: Post-procedure 72 hours (± 12 hours)
Incidence of Any Intracranial Hemorrhage
Time frame: Post-procedure 72 hours (± 12 hours)
Incidence of Adverse Events (AEs)
Time frame: Through study completion, up to 90 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Through study completion, up to 90 days
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 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Carotid Artery Stenosis
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingObservational study
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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 Balloon Guide Catheter and Distal Filter Protection Device in people with Carotid Artery Stenosis, run by Beijing Anzhen Hospital 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 5 inclusion and 14 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 2 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 Xiaochuan Huo, Doctor, Doctor (+86 13716292262, hxc810909@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 Ischemic Lesions on Diffusion-Weighted Imaging (DWI) (time frame: Post-procedure 72 hours (plus or minus 12 hours)). 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 2 Sep 2026.