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

ConditionsTransradial Carotid Artery StentingNovel Composite-tip Guiding Catheter
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Composite-Tip Transradial Neurovascular Distal Access Catheter

    Device

    Carotid Artery Stenting via Transradial Access Using a Composite-Tip Neurovascular Distal Access Catheter

  • Straight or Single-Curve Tip Guiding Catheter

    Device

    Carotid Artery Stenting via Transradial Access Using Straight or Single-Curve Tip Guiding Catheter

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Composite-Tip Transradial Neurovascular Distal Access CatheterExperimental treatment 1 intervention
Group B: Straight or Single-Curve Tip Guiding CatheterActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Transradial Access Success Rate Within 10 Minutes

Time frame
Intra-procedure

Secondary outcomes

1

Success Rate of Transradial Access Carotid Artery Stenting

Time frame
Immediately post-procedure
2

Primary Success Rate of Transradial Access Establishment

Time frame
Intra-procedure
3

Transradial-to-Transfemoral Conversion Rate

Time frame
Intra-procedure
4

X-ray Radiation Exposure

Time frame
Intra-procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Anzhen Hospital

Lead sponsor

Source ClinicalTrials.gov
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