NCT06557135Completed
Brachial Versus Femoral Access for Carotid Artery Stenting
Brachial vErsus Femoral Access for carotId Artery sTenting: a Multicenter Randomized Clinical Trial (BEFIT)
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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;
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 235 (actual)
- First submitted
- 12 Aug 2024
- Start date
- 27 Sept 2024
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Stroke
- NCT number
- NCT06557135
What you commit to
- Study type: Interventional
- Participants enrolled: 235
- From 27 Sept 2024 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe functional damage to important organs, assessed by clinical physicians to have high surgical risks and intolerant of interventional surgery
Other illness
- Ischemic stroke within the past 2 weeks
- 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
Lab values
- 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
Other
- Symptomatic stenosis or occlusion of multiple vessels at the same time
- Intravascular intervention for multiple vessel lesions at the same time
- Unable to understand or sign the informed consent form
- Baseline modified Rankin scale greater than or equal to 2
- Expected survival is less than 6 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.