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

Официальное название

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

Обзор

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

Вмешательства

• Устройство Composite-Tip Transradial Neurovascular Distal Access Catheter
  Carotid Artery Stenting via Transradial Access Using a Composite-Tip Neurovascular Distal Access Catheter
• Устройство Straight or Single-Curve Tip Guiding Catheter
  Carotid Artery Stenting via Transradial Access Using Straight or Single-Curve Tip Guiding Catheter

Первичные конечные точки

• Transradial Access Success Rate Within 10 Minutes [Срок оценки: Intra-procedure]

Вторичные конечные точки (12)

• Success Rate of Transradial Access Carotid Artery Stenting [Срок оценки: Immediately post-procedure]
• Primary Success Rate of Transradial Access Establishment [Срок оценки: Intra-procedure]
• Transradial-to-Transfemoral Conversion Rate [Срок оценки: Intra-procedure]
• X-ray Radiation Exposure [Срок оценки: Intra-procedure]
• Clinician User Experience Assessment [Срок оценки: Immediately post-procedure]
• National Institutes of Health Stroke Scale (NIHSS) Score [Срок оценки: Pre-discharge]
• Post-Procedure Modified Rankin Scale (mRS) Score [Срок оценки: Pre-discharge]
• Incidence Rate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [Срок оценки: Pre-discharge，30 days post-procedure]
• Incidence Rate of All-Cause Death [Срок оценки: Pre-discharge，30 days post-procedure]
• Incidence Rate of Any Stroke [Срок оценки: Pre-discharge，30 days post-procedure]
• Incidence Rate of Target Vessel-Related Ischemic Stroke [Срок оценки: Pre-discharge，30 days post-procedure]
• Incidence Rate of Any Myocardial Infarction [Срок оценки: Pre-discharge，30 days post-procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Anzhen Hospital. Capital Medical University — Пекин

Идентификаторы

NCT: NCT07377422 · BC-CR202501 · 2025AZC2008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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