The First Affiliated Hospital with Nanjing Medical University
Phase
Not applicable
Started
2024-09-27
Last updated
2025-07-18
Condition(s) studied
Carotid Artery Stenosis Without Infarction (Disorder)Ischemic Stroke
Investigational drug(s) / intervention(s)
Carotid Artery Stenting (CAS)
Carotid Artery Stenting (CAS): CAS involves inserting a catheter or tube into an artery in the brachial or the femoral, and then threading the catheter through the arteries of the body to the location of the stenosis within the carotid artery in the neck. A stent is then placed in the stenosis and holds the artery open.
Study summary
Study purpose:
A multicenter, prospective and randomized study is planned to compare the clinical outcomes of carotid artery stenting via brachial artery access and femoral artery access.
Eligible participants will be randomly assigned 1:1 to the brachial artery group or the femoral artery group.
Primary endpoint: surgical success rate.
Secondary endpoints:
1. Operation time (time from first arterial puncture to last angiography)
2. Serious adverse events (SAE) within 90 days;
3. Access puncture complications;
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Clinical diagnosis of stenosis at the origin of the carotid artery with indications for neuro-interventional treatment (symptomatic stenosis \>50%; asymptomatic stenosis \>70%)
* Aged 18 or above
* With palpable brachial and femoral arteries
* The patient or his/her agent understands the purpose and needs of this study and signs the informed consent
Exclusion Criteria:
* Symptomatic stenosis or occlusion of multiple vessels at the same time
* Intravascular intervention for multiple vessel lesions at the same time
* Ischemic stroke within the past 2 weeks
* Any active bleeding, severe anaemia, or coagulation disorder. At least one of the following laboratory tests must be met: haemoglobin \< 10g/dL, or platelet count \< 100,000 /μ L, or unadjusted INR \>1.5, or PT exceeds the upper limit of normal by 1 minute or heparin-induced thrombocytopenia
* A large-area cerebral infarction stroke on the same side with sequelae may affect the judgment of the study endpoint
* A history of cerebral hemorrhage in the past six months
* Any condition that may interfere with digital subtraction angiography (DSA) or cause unsafe percutaneous arterial access Participating in other clinical trials, in the research stage or follow-up stage
* Contraindications to cerebral angiography, such as allergy to iodine contrast agents and renal insufficiency
* Unable to understand or sign the informed consent form
* Severe functional damage to important organs, assessed by clinical physicians to have high surgical risks and intolerant of interventional surgery
* Baseline modified Rankin scale greater than or equal to 2
* Expected survival is less than 6 months
Primary outcome measure(s)
Successful rate of CAS — 24 hours Successful carotid artery stenting (CAS) is defined as access devices can be established, interventional devices can reach the lesion site, operations such as distal brain protection device release, balloon expansion and stent implantation, withdrawal protection device can be completed successfully, and residual stenosis \< 30%.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangsu
Recruiting
More The First Affiliated Hospital with Nanjing Medical University trials in China
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.
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