Safety and Efficacy of a Novel Composite-Tip Guiding Catheter in Transcarotid Artery Stenting Via… (NCT07377422) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy of a Novel Composite-Tip Guiding Catheter in Transcarotid Artery Stenting Via Transradial Access
China204 participantsStarted 2026-01-19
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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) ;
✓. 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;
✕. Contraindicated in patients with severe allergies to interventional devices or agents related to carotid stenting (e.g., lidocaine, contrast agents, aspirin, clopidogrel);
. 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;