Composite-tip guiding catheter for transradial carotid stenting

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial evaluates a novel composite-tip guiding catheter used through the radial artery to perform carotid artery stenting. Participants are adults with carotid stenosis confirmed by CTA and meeting specific symptomatic or asymptomatic criteria. The study uses endpoints focused on safety and effectiveness of the catheter in enabling navigation and successful stenting. Procedures will involve transradial access with either straight or single-curve catheters as distal access devices. No phase information is provided for this interventional investigation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Anzhen Hospital. Capital Medical University
  Beijing, China Recruiting

Study contacts

• Study coordinator: Xu Guo
• Email: guo_ball@hotmail.com
• Phone: +86-13810124068

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.