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Clinical Trials in China / NCT07377422
Starting soon 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
Sponsor
Beijing Anzhen Hospital
Phase
Not applicable
Started
2026-01-19
Last updated
2026-01-29

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)

Trial sites (1)

FacilityCityRegionStatus
Beijing Anzhen Hospital. Capital Medical University Beijing China

More Beijing Anzhen Hospital trials in China

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