Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balloon Guide Catheter | Device | A catheter with a balloon at the distal tip, used to temporarily arrest flow and aspirate debris during the stenting procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-procedure 72 hours (plus or minus 12 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intra-operative |
| Total Volume of New Ischemic Lesions on DWI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaochuan Huo, Doctor, Doctor | Contact | +86 13716292262 | hxc810909@163.com | |
| Xin Tong, Doctor | Contact | +86 17810651085 | tomice123@foxmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital Affiliated to Capital Medical University | Recruiting | Beijing | Beijing Municipality | 101118 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D057505 | Embolic Protection Devices |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Distal Filter Protection Device | Device | A mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure. |
|
|
The total volume (in milliliters) of new ischemic lesions measured on DWI MRI.
| Post-procedure 72 hours (± 12 hours) |
| Incidence of New Symptomatic Ischemic Stroke | Occurrence of a new ischemic stroke presenting with clinical symptoms. | 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. | Post-procedure 72 hours (± 12 hours) |
| All-Cause Mortality at 30 Days | 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 | 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. | 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. | 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. | 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. | 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. | 90 days (± 7 days) |
| Incidence of Symptomatic Intracranial Hemorrhage | Post-procedure 72 hours (± 12 hours) |
| Incidence of Any Intracranial Hemorrhage | Post-procedure 72 hours (± 12 hours) |
| Incidence of Adverse Events (AEs) | Number of participants with adverse events. | Through study completion, up to 90 days |
| Incidence of Serious Adverse Events (SAEs) | Number of participants with serious adverse events. | Through study completion, up to 90 days |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |