Safety and Efficacy of a Novel Composite-Tip Guiding Catheter in Transcarotid Artery Stenting Via Transradial Access

Safety and Efficacy of a Novel Composite-Tip Guiding Catheter in Transcarotid Artery Stenting Via Transradial Access: A Prospective, Multicenter, Randomized Controlled Trial

This study aims to evaluate the safety and efficacy of the novel composite-tip guiding catheter for transradial access in Carotid Artery Stenting procedures

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.