Brachial versus femoral access for carotid artery stenting
Brachial vErsus Femoral Access for carotId Artery sTenting: a Multicenter Randomized Clinical Trial (BEFIT)
This trial will test whether using the brachial artery or the femoral artery for carotid artery stenting leads to better surgical success and fewer complications in adults with carotid artery narrowing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06557135 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized 1:1 study comparing carotid artery stenting performed via brachial artery access versus femoral artery access. Eligible adults with symptomatic (>50%) or asymptomatic (>70%) carotid stenosis who have palpable brachial and femoral arteries will be randomized to one access route. The primary endpoint is surgical success rate, and secondary endpoints include operation time, serious adverse events within 90 days, and access puncture complications. The trial tests whether the brachial route, which has a larger caliber than the radial artery and may allow earlier mobilization than femoral access, offers comparable or improved outcomes.
Who should consider this trial
Good fit: Adults (≥18) with carotid artery stenosis meeting intervention criteria (symptomatic >50% or asymptomatic >70%), who are candidates for carotid stenting and have palpable brachial and femoral arteries, are ideal candidates.
Not a fit: Patients with recent ischemic stroke within 2 weeks, concurrent multi-vessel symptomatic disease or planned multivessel interventions, active bleeding or significant coagulopathy, large ipsilateral infarction with sequelae, or non-palpable access arteries are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, this could provide a safer or more comfortable access option that reduces access complications, shortens bed rest, and speeds recovery for patients needing carotid stenting.
How similar studies have performed: While cardiac studies and some neurointerventional reports have shown advantages of alternative access routes like radial or brachial, randomized evidence specifically comparing brachial versus femoral access for carotid stenting is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Sheng Liu, Professor — The First Affiliated Hospital with Nanjing Medical University
- Study coordinator: kai Qiu, Doctor
- Email: 2232723655@qq.com
- Phone: +8615895907771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.