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| ID | Type | Description | Link |
|---|---|---|---|
| 2025AZC2008 | Other Grant/Funding Number | Beijing Anzhen Hospital. Capital Medical University |
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This study aims to evaluate the safety and efficacy of the novel composite-tip guiding catheter for transradial access in Carotid Artery Stenting procedures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Composite-Tip Transradial Neurovascular Distal Access Catheter | Experimental |
| |
| Straight or Single-Curve Tip Guiding Catheter | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Composite-Tip Transradial Neurovascular Distal Access Catheter | Device | Carotid Artery Stenting via Transradial Access Using a Composite-Tip Neurovascular Distal Access Catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transradial Access Success Rate Within 10 Minutes | Intra-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate of Transradial Access Carotid Artery Stenting | Immediately post-procedure | |
| Primary Success Rate of Transradial Access Establishment | Intra-procedure | |
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Inclusion Criteria:
Age ≥18 years;
Patients who are candidates for endovascular intervention with CTA-confirmed stenosis in the common carotid artery or C1 segment of internal carotid artery(Symptomatic: ≥50% stenosis; Asymptomatic: 70%-99% stenosis)(NASCET criteria) ;
Symptomatic carotid artery stenosis: Non-disabling ischemic stroke or transient ischemic symptoms (TIA, including hemispheric events or transient monocular blindness) within 180 days prior to randomization;
Palpable radial pulse and negative Allen's test (confirming adequate ulnar collateral circulation);
Feasible transradial access with achievable device delivery to the target lesion per operator assessment;
Patients or legally authorized representatives comprehend the study purpose, voluntarily participate with signed informed consent, and commit to complete follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Guo | Contact | +86-13810124068 | guo_ball@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital. Capital Medical University | Beijing | 100029 | China |
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| Straight or Single-Curve Tip Guiding Catheter | Device | Carotid Artery Stenting via Transradial Access Using Straight or Single-Curve Tip Guiding Catheter |
|
| Transradial-to-Transfemoral Conversion Rate |
| Intra-procedure |
| X-ray Radiation Exposure | Intra-procedure |
| Clinician User Experience Assessment | Immediately post-procedure |
| National Institutes of Health Stroke Scale (NIHSS) Score | Pre-discharge |
| Post-Procedure Modified Rankin Scale (mRS) Score | Pre-discharge |
| Incidence Rate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | Pre-discharge,30 days post-procedure |
| Incidence Rate of All-Cause Death | Pre-discharge,30 days post-procedure |
| Incidence Rate of Any Stroke | Pre-discharge,30 days post-procedure |
| Incidence Rate of Target Vessel-Related Ischemic Stroke | Pre-discharge,30 days post-procedure |
| Incidence Rate of Any Myocardial Infarction | Pre-discharge,30 days post-procedure |
| Incidence Rate of Any Revascularization | Pre-discharge,30 days post-procedure |
| Incidence Rate of Radial Artery Occlusion | Pre-discharge |