Transradial Carotid Artery StentingNCT07377422
Safety and Efficacy of a Novel Composite-Tip Guiding Catheter in Transcarotid Artery Stenting Via Transradial Access
A study testing Composite-Tip Transradial Neurovascular Distal Access Catheter and Straight or Single-Curve Tip Guiding Catheter in people with Transradial Carotid Artery Stenting and Novel Composite-tip Guiding Catheter, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transradial Carotid Artery Stenting, Novel Composite-tip Guiding Catheter
- What is being tested?
- Composite-Tip Transradial Neurovascular Distal Access Catheter and Straight or Single-Curve Tip Guiding Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 16 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital. Capital Medical University
Beijing, 100029
Xu Guo, +86-13810124068, guo_ball@hotmail.com
About this study
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
This study aims to evaluate the safety and efficacy of the novel composite-tip guiding catheter for transradial access in Carotid Artery Stenting procedures
- Being tested
- Composite-Tip Transradial Neurovascular Distal Access Catheter, Straight or Single-Curve Tip Guiding Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite-Tip Transradial Neurovascular Distal Access CatheterDevice
Carotid Artery Stenting via Transradial Access Using a Composite-Tip Neurovascular Distal Access Catheter
Straight or Single-Curve Tip Guiding CatheterDevice
Carotid Artery Stenting via Transradial Access Using Straight or Single-Curve Tip Guiding Catheter
| Study group | Role | What they receive |
|---|---|---|
| Composite-Tip Transradial Neurovascular Distal Access Catheter | Experimental | Not described Receives: Device: Composite-Tip Transradial Neurovascular Distal Access Catheter |
| Straight or Single-Curve Tip Guiding Catheter | Active comparator | Not described Receives: Device: Straight or Single-Curve Tip Guiding Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transradial Access Success Rate Within 10 Minutes
Measured: Intra-procedure
Secondary outcomes (14)
Success Rate of Transradial Access Carotid Artery Stenting
Measured: Immediately post-procedure
Primary Success Rate of Transradial Access Establishment
Measured: Intra-procedure
Transradial-to-Transfemoral Conversion Rate
Measured: Intra-procedure
X-ray Radiation Exposure
Measured: Intra-procedure
Clinician User Experience Assessment
Measured: Immediately post-procedure
National Institutes of Health Stroke Scale (NIHSS) Score
Measured: Pre-discharge
Post-Procedure Modified Rankin Scale (mRS) Score
Measured: Pre-discharge
Incidence Rate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Measured: Pre-discharge，30 days post-procedure
Incidence Rate of All-Cause Death
Measured: Pre-discharge，30 days post-procedure
Incidence Rate of Any Stroke
Measured: Pre-discharge，30 days post-procedure
Incidence Rate of Target Vessel-Related Ischemic Stroke
Measured: Pre-discharge，30 days post-procedure
Incidence Rate of Any Myocardial Infarction
Measured: Pre-discharge，30 days post-procedure
Incidence Rate of Any Revascularization
Measured: Pre-discharge，30 days post-procedure
Incidence Rate of Radial Artery Occlusion
Measured: Pre-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 May 2026
- Primary completion16 Jun 2027 (estimated)
- Study completion16 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transradial Carotid Artery StentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Xu, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377422
- Sponsor's protocol ID
- BC-CR202501
- Other IDs
- 2025AZC2008
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided