Wrist access may be safer for carotid stenting in major new trial
NCT ID NCT05416853
First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times
Summary
This study compares two ways to perform carotid artery stenting—a procedure that opens narrowed neck arteries to prevent stroke. The standard method uses an artery in the groin, while the experimental method uses an artery in the wrist. Researchers will enroll 3000 adults with significant carotid narrowing to see if the wrist approach is as safe and effective, with fewer complications and more comfort.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
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
-
1,200 people
The number who actually took part.
- Started
-
Jul 2022
- Finished
-
Mar 2026
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * General inclusion criteria 1\) Age≥18 years old * Clinical inclusion criteria 1. Symptomatic stenosis: patients had a transient ischemic attack (TIA), amaurosis, or minor nondisabling stroke involving the target carotid artery within 180 days before randomization. 2. Asymptomatic stenosis: The results of medical history, physical examination and neurological examination do not suggest ischemic symptoms in the target carotid artery. If artery stenosis degree reache the standard, but there are any one or more of the following symptoms including: non-carotid artery symptoms; contralateral carotid artery symptoms; time from symptom to randomization more than 180 days; and vertebrobasilar artery symptoms. In these situations, patients are considered to be asymptomatic. 3. Pulsation is palpable in the radial and femoral arteries, and the radial artery must meet any of the following criteria: Allen test or Barbeau test suggesting that ulnar artery collateral circulation is good, or preoperative ultrasound confirming that the radial artery and ulnar artery are well developed. 4. No family planning within half one year after informed consent signed, or negative pregnancy test for women with childbearing potential. 5. Patients or their guardians can understand the study purpose, voluntarily participate in the trial, sign informed consent, and complete follow-up visits. * Vascular inclusion criteria 1. Lesions located in the internal carotid artery, with or without involvement of the adjacent common carotid artery (CCA). 2. For symptomatic patients, at least one of the following conditions should be met: stenosis of 70% or more on ultrasonography; 70% or more on computed tomographic angiography (CTA) or magnetic resonance angiography (MRA); 50% or more on digital subtraction angiography (DSA) according to NASCET standard. 3. For asymptomatic patients, at least one of the following conditions should be met: stenosis of 70% or more on ultrasonography; 80% or more on CTA or MRA; 60% or more on DSA according to NASCET standard. 4. When bilateral carotid stenosis presented, only unilateral carotid artery can be treated. The other carotid artery, as a non-study artery, should be dealt with 30 days before randomization or 30 days after treatment. 5. According to clinician experience, the operation access would be reasonable and the surgical instruments could be successfully delivered to the lesion site. Exclusion Criteria: * General exclusion criteria 1. Progressive stroke. 2. Allergic to drugs associated with carotid artery stenting, such as lidocaine, aspirin, clopidogrel, etc. 3. Allergic to contrast media or interventional device. 4. Any active hemorrhage, severe anemia, coagulation disorders, or unnecessary blood transfusion treatment. Meet at least one of the following laboratory tests: hemoglobin \< 10g/dL, or platelet count \< 100000 /μ L, or unadjusted INR \>1.5, or PT beyond upper limit of normal for 1 minute, or heparin-induced thrombocytopenia. 5. Previous ipsilateral large cerebral infarction stroke with sequelae, which can affect the judgment of the study end point. 6. Severe cognitive disorder, unable to cooperate with treatment or postoperative evaluation. 7. Spontaneous intracranial hemorrhage occurred 12 months prior to informed consent written. Ischemic stroke hemorrhage transformation occurred 3 months prior to informed consent signed. 8. A new-onset stroke occurred 7 days prior to informed consent signed, which has a high hemorrhagic transformation risk after preoperative imaging evaluation. 9. Any condition that could interfere with digital subtraction angiography (DSA) or make percutaneous arterial access unsafe. 10. Neurological disorders occurred 2 years prior to informed consent signed, which has transient or fixed neurological deficits, cannot be distinguished from TIA or stroke. 11. Participating in other clinical trials, in the research phase or follow-up phase. 12. Unable to understand or sign the informed consent. 13. Myocardial infarction within 30 days. 14. High surgical risk, intolerance to interventional surgery, e.g., coronary artery stenosis ≥70% without or unable to revascularization; ejection fraction \< 30% or NYHA classification ≥class III; stable angina pectoris (static angina pectoris with ECG changes); organ transplantation (such as heart, lung, liver and kidney) planned or under evaluation; malignant tumour or respiratory insufficiency making life expectancy less than 5 years or FEV1\< 30%(prediction); dialysis-dependent renal failure; poorly controlled diabetes mellitus(fast serum glucose \>400 mg/dl and urine ketone \> +2). 15. Diseases or anatomical features that would prevent from carotid artery stenting, such as pathway problems caused by cervical radiation therapy, and cervical space occupying lesion compressing carotid artery * Vascular exclusion criteria 1. Severe vascular tortuosity or dissection that influence catheters delivering 2. Stenting, balloon dilation or coiling were performed in ipsilateral vessels in the past. 3. Extensive or diffuse atherosclerotic disease involving the aortic arch and the proximal common carotid artery, which would influence catheters delivering 4. Besides the target vessel, there are also ipsilateral intracranial or extracranial arteries stenosis larger than the target lesion, aneurysms with the longest diameter ≥5 mm, cerebrovascular AVM(arteriovenous malformation), or other cerebrovascular disease with abnormal cerebral angiography. 5. Ipsilateral carotid artery chronic occlusions. 6. Plan to perform endovascular tretment of other arteries at the same time, including vertebral arteries.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Carotid artery diseases are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
-
University of Science and Technology of China
Hefei, Anhui, 210000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to catch a hidden heart rhythm after stroke
- Blood test may reveal who recovers after a stroke
- Can a smart bracelet and app stop a second stroke?
- Can powerful cholesterol drugs remodel dangerous artery plaques?