An interventional study of Balloon Guide Catheter and Distal Filter Protection Device in Carotid Artery Stenosis, sponsored by Beijing Anzhen Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment
Among 70 studies in Carotid Stenosis with a site in China — 32 open to participants now, 36 under way, 1 of them phase 3. Carotid Stenosis · China.
Among the 70 studies in Carotid Stenosis with a site in China, this one is the 12th largest by planned enrollment of the 36 interventional ones that give a count, is one of 8 that started in 2025, is one of 25 with no phase, reaches primary completion later than 23 of the 35 other live ones, and was the 63rd registered.
364 studies on the registry are indexed under Carotid Stenosis; 85 are open to participants now.
Browse Carotid Stenosis studies →32 of the 70 studies in Carotid Stenosis with a site in China are open now. Recruiting first, the newest first:
The Fifth Affiliated Hospital of Wenzhou Medical University & Lishui Central Hospital · Sites in China
Ages 30–80
Beijing Tiantan Hospital · Sites in China
Ages 18+
General Hospital of Shenyang Military Region · Sites in China
Ages 40+
Chinese PLA General Hospital · Sites in China
Ages 10–90
Changhai Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 60 Carotid Stenosis studies recruiting now, 38 (63%) set no upper age limit and none (0%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
70 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 8 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 296 is above the median of 103 across 189 interventional studies indexed under Carotid Stenosis.
Median enrollment 177 across the 36 interventional studies, 200 across the 34 observational. Of the 13 that completed or were terminated, 4 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 70 have an industry lead sponsor. The 10 most frequent:
Beijing Anzhen Hospital is the lead sponsor of 192 studies on the registry; 102 are open to participants now.
Beijing Anzhen Hospital has 2 studies filed under Carotid Stenosis — fewer than ten, so there is no comparison to draw.
5 of the studies in Carotid Stenosis with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07004673Ruijin Hospital18F FDG and 68Ga FAPI PET/MR Imaging of Carotid Artery Plaque Vulnerability: A Clinical Study in Carotid Artery Plaque Patients | 2026-12-31 |
| NCT05134246Xuanwu Hospital, BeijingCarotid Revascularization for Radiation Induced Carotid Artery Stenosis | 2026-12-31 |
| NCT07036991Changhai HospitalA Cohort Study Comparing PCSK9 Inhibitor Plus Statin With Statin Monotherapy for Carotid Artery Stenosis | 2027-06-01 |
| NCT07247864Beijing Anzhen HospitalBalloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting | 2027-09-01 |
| NCT07412249General Hospital of Shenyang Military RegionRemote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis | 2027-11-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 70 studies in Carotid Stenosis with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Balloon Guide Catheter · Device: Distal Filter Protection Device
Patients in this group will undergo carotid artery stenting (CAS) using a standard guiding catheter and a distal filter protection device alone.
Device: Distal Filter Protection Device
A catheter with a balloon at the distal tip, used to temporarily arrest flow and aspirate debris during the stenting procedure.
Also known as: BGC
A mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure.
Also known as: Embolic Protection Device, EPD
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.
Time frame: Post-procedure 72 hours (plus or minus 12 hours)
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.
Time frame: Intra-operative
Total Volume of New Ischemic Lesions on DWI
The total volume (in milliliters) of new ischemic lesions measured on DWI MRI.
Time frame: Post-procedure 72 hours (± 12 hours)
Incidence of New Symptomatic Ischemic Stroke
Occurrence of a new ischemic stroke presenting with clinical symptoms.
Time frame: 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.
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
Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 1
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
Number of participants with adverse events.
Time frame: Through study completion, up to 90 days
Incidence of Serious Adverse Events (SAEs)
Number of participants with serious adverse events.
Time frame: Through study completion, up to 90 days
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Sep 2027, 20 months after the start.
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 20 months is below 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.
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