NCT06557135

Brachial Versus Femoral Access for Carotid Artery Stenting

Brachial vErsus Femoral Access for carotId Artery sTenting: a Multicenter Randomized Clinical Trial (BEFIT)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 226 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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;

Detailed description

With the improvement of treatment concepts and the continuous innovation of interventional devices/interventional technologies, neurointervention has become the preferred treatment method for many cerebrovascular diseases. Among them, the femoral artery is the most commonly used access, because the femoral artery is superficial, easy to touch, and the relatively large vessel diameter allows most neurointerventional surgeries to proceed smoothly. However, the femoral artery access also has the disadvantages of long bed rest time, exposure to private parts, and prolonged hospitalization. Thanks to the great success of radial artery access in cardiac intervention, radial artery access is increasingly being used in neurointervention. However, due to the thin radial artery, there is a significantly increased risk of complications (radial artery spasm, radial artery occlusion) during large-cavity nerve intervention, and the operation time is significantly prolonged. Therefore, the overall proportion of neurointerventional treatment via radial artery access in clinical practice is less than 12%. As the superior vascular trunk of the radial artery, the brachial artery has a larger diameter and is theoretically more suitable to replace the radial artery for large-bore intervention. Anatomically, the brachial artery is superficial and easy to touch in the antecubital fossa, and there are no important vessels and nerves in front of the blood vessel, and the posterior is the distal humeral platform, which is easy for brachial artery puncture and postoperative compression hemostasis. Studies have shown that thrombectomy for cerebral artery occlusion and carotid artery stent placement can be safely performed through the brachial artery. However, current studies are based on single-center small sample studies, and there is still a lack of large-sample randomized controlled trials to verify the safety and effectiveness of neurointervention via the brachial artery. This study intends to conduct a multicenter, prospective, and randomized study to compare the clinical results of carotid artery stent placement via the brachial and femoral artery access.

Conditions

• Carotid Artery Stenosis Without Infarction (Disorder)
• Ischemic Stroke

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2024-09-27
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-08-16
• Last updated: 2025-07-18

Locations

1 site across 1 country: China