Wrist access catheter could make carotid stenting safer and faster
NCT ID NCT07377422
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new type of catheter (a thin tube) designed to make carotid artery stenting easier and safer when done through the wrist. About 204 people with blocked neck arteries will be randomly assigned to get the new catheter or a standard one. The main goal is to see if the new catheter can successfully reach the artery within 10 minutes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 204 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Anzhen Hospital. Capital Medical University
Beijing, 100029, China
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