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Not yet recruiting NCT07377422

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

No phase Interventional Transradial Carotid Artery Stenting Novel Composite-tip Guiding Catheter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Composite-Tip Transradial Neurovascular Distal Access Catheter, Straight or Single-Curve Tip Guiding Catheter.
Who it may be relevant to
Registry conditions: Transradial Carotid Artery Stenting, Novel Composite-tip Guiding Catheter. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Transradial Access Success Rate Within 10 Minutes [Time frame: Intra-procedure]
Secondary outcome measures (12)
  • Success Rate of Transradial Access Carotid Artery Stenting [Time frame: Immediately post-procedure]
  • Primary Success Rate of Transradial Access Establishment [Time frame: Intra-procedure]
  • Transradial-to-Transfemoral Conversion Rate [Time frame: Intra-procedure]
  • X-ray Radiation Exposure [Time frame: Intra-procedure]
  • Clinician User Experience Assessment [Time frame: Immediately post-procedure]
  • National Institutes of Health Stroke Scale (NIHSS) Score [Time frame: Pre-discharge]
  • Post-Procedure Modified Rankin Scale (mRS) Score [Time frame: Pre-discharge]
  • Incidence Rate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [Time frame: Pre-discharge，30 days post-procedure]
  • Incidence Rate of All-Cause Death [Time frame: Pre-discharge，30 days post-procedure]
  • Incidence Rate of Any Stroke [Time frame: Pre-discharge，30 days post-procedure]
  • Incidence Rate of Target Vessel-Related Ischemic Stroke [Time frame: Pre-discharge，30 days post-procedure]
  • Incidence Rate of Any Myocardial Infarction [Time frame: Pre-discharge，30 days post-procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Anzhen Hospital. Capital Medical University — Beijing

Identifiers

NCT: NCT07377422 · BC-CR202501 · 2025AZC2008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗