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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Transradial Carotid Artery Stenting; Novel Composite-tip Guiding Catheter
• Intervention / Treatment: Device: Composite-Tip Transradial Neurovascular Distal Access Catheter; Device: Straight or Single-Curve Tip Guiding Catheter

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xu Guo; Phone Number: +86-13810124068; Email: guo_ball@hotmail.com

Study Locations

• China
  • Beijing, China, 100029
    • Beijing Anzhen Hospital. Capital Medical University
    • Contact: Xu Guo; Phone Number: +86-13810124068; Email: guo_ball@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Composite-Tip Transradial Neurovascular Distal Access Catheter	Device: Composite-Tip Transradial Neurovascular Distal Access Catheter; Carotid Artery Stenting via Transradial Access Using a Composite-Tip Neurovascular Distal Access Catheter
Active Comparator: Straight or Single-Curve Tip Guiding Catheter	Device: Straight or Single-Curve Tip Guiding Catheter; Carotid Artery Stenting via Transradial Access Using Straight or Single-Curve Tip Guiding Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Transradial Access Success Rate Within 10 Minutes	Intra-procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Success Rate of Transradial Access Carotid Artery Stenting	Immediately post-procedure
Primary Success Rate of Transradial Access Establishment	Intra-procedure
Transradial-to-Transfemoral Conversion Rate	Intra-procedure
X-ray Radiation Exposure	Intra-procedure
Clinician User Experience Assessment	Immediately post-procedure
National Institutes of Health Stroke Scale (NIHSS) Score	Pre-discharge
Post-Procedure Modified Rankin Scale (mRS) Score	Pre-discharge
Incidence Rate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)	Pre-discharge，30 days post-procedure
Incidence Rate of All-Cause Death	Pre-discharge，30 days post-procedure
Incidence Rate of Any Stroke	Pre-discharge，30 days post-procedure
Incidence Rate of Target Vessel-Related Ischemic Stroke	Pre-discharge，30 days post-procedure
Incidence Rate of Any Myocardial Infarction	Pre-discharge，30 days post-procedure
Incidence Rate of Any Revascularization	Pre-discharge，30 days post-procedure
Incidence Rate of Radial Artery Occlusion	Pre-discharge

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 19, 2026
• Primary Completion (Estimated): June 16, 2027
• Study Completion (Estimated): August 16, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BC-CR202501; 2025AZC2008 (Other Grant/Funding Number: Beijing Anzhen Hospital. Capital Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No