Brachial Versus Femoral Access for Carotid Artery Stenting
Brachial vErsus Femoral Access for carotId Artery sTenting: a Multicenter Randomized Clinical Trial (BEFIT)
The First Affiliated Hospital with Nanjing Medical University
226 participants
Sep 27, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria12
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06557135