Novel Composite-tip Guiding Catheter, Transradial Carotid Artery Stenting
Conditions
Brief summary
This study aims to evaluate the safety and efficacy of the novel composite-tip guiding catheter for transradial access in Carotid Artery Stenting procedures
Interventions
DEVICEComposite-Tip Transradial Neurovascular Distal Access Catheter
Carotid Artery Stenting via Transradial Access Using a Composite-Tip Neurovascular Distal Access Catheter
DEVICEStraight or Single-Curve Tip Guiding Catheter
Carotid Artery Stenting via Transradial Access Using Straight or Single-Curve Tip Guiding Catheter
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years; 2. 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; * Asymptomatic Carotid Stenosis: No history or examination findings suggestive of ipsilateral carotid ischemic symptoms(Non-carotid symptoms, contralateral carotid symptoms, symptom onset \>180 days prior to randomization, or vertebrobasilar symptoms are classified as asymptomatic). 3. Palpable radial pulse and negative Allen's test (confirming adequate ulnar collateral circulation); 4. Feasible transradial access with achievable device delivery to the target lesion per operator assessment; 5. Patients or legally authorized representatives comprehend the study purpose, voluntarily participate with signed informed consent, and commit to complete follow-up.
Exclusion criteria
1. Patients with severe vascular tortuosity/dissection, extensive or diffuse atherosclerotic lesions involving the aortic arch or proximal common carotid artery, or post-surgical anatomy impeding catheter delivery; 2. Severe stenosis, aneurysms ≥5mm in maximum diameter, arteriovenous malformations (AVM), or other significant cerebrovascular diseases in ipsilateral intracranial/extracranial arteries beyond the target vessel; 3. Patients requiring simultaneous bilateral carotid interventions; 4. Contraindicated in patients with severe allergies to interventional devices or agents related to carotid stenting (e.g., lidocaine, contrast agents, aspirin, clopidogrel); 5. Preprocedural mRS ≥3; 6. Progressive stroke within 2 weeks, hemorrhagic transformation of ischemic stroke within 3 months, or spontaneous intracranial hemorrhage within 12 months; 7. Severe hematologic disorders (active bleeding, severe anemia, coagulopathy, or transfusion dependency), severe heart failure, severe hepatic/renal impairment, or acute coronary syndrome; 8. Malignancy or life expectancy \<1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transradial Access Success Rate Within 10 Minutes | Intra-procedure |
Secondary
| Measure | Time frame |
|---|---|
| Success Rate of Transradial Access Carotid Artery Stenting | Immediately post-procedure |
| Primary Success Rate of Transradial Access Establishment | Intra-procedure |
| 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 |
Countries
China
Contacts
CONTACTXu Guo
Outcome results
None listed