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

Capital Medical University

Status

Not yet enrolling

Conditions

Transradial Carotid Artery Stenting

Novel Composite-tip Guiding Catheter

Treatments

Device: Straight or Single-Curve Tip Guiding Catheter

Device: Composite-Tip Transradial Neurovascular Distal Access Catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT07377422

2025AZC2008 (Other Grant/Funding Number)

BC-CR202501

Details and patient eligibility

About

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

Enrollment

204 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;
  - 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).
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

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;
Severe stenosis, aneurysms ≥5mm in maximum diameter, arteriovenous malformations (AVM), or other significant cerebrovascular diseases in ipsilateral intracranial/extracranial arteries beyond the target vessel;
Patients requiring simultaneous bilateral carotid interventions;
Contraindicated in patients with severe allergies to interventional devices or agents related to carotid stenting (e.g., lidocaine, contrast agents, aspirin, clopidogrel);
Preprocedural mRS ≥3;
Progressive stroke within 2 weeks, hemorrhagic transformation of ischemic stroke within 3 months, or spontaneous intracranial hemorrhage within 12 months;
Severe hematologic disorders (active bleeding, severe anemia, coagulopathy, or transfusion dependency), severe heart failure, severe hepatic/renal impairment, or acute coronary syndrome;
Malignancy or life expectancy <1 year.