Ireland
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Recruiting Not applicable

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

NCT07377422 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-05-01
Last updated
2026-10-05

Condition(s) studied

Transradial Carotid Artery StentingNovel Composite-tip Guiding Catheter

Investigational drug(s) / intervention(s)

Composite-Tip Transradial Neurovascular Distal Access CatheterStraight or Single-Curve Tip Guiding Catheter

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

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

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Transradial Access Success Rate Within 10 Minutes — Intra-procedure

Trial sites (1)

FacilityCityRegionStatus
Beijing Anzhen Hospital. Capital Medical University Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07377422 on ClinicalTrials.gov ↗ ← All trials in China