Brachial vErsus Femoral Access for carotId Artery sTenting: a Multicenter Randomized Clinical Trial (BEFIT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Successful rate of CAS
研究概览
简要总结
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:
- Operation time (time from first arterial puncture to last angiography)
- Serious adverse events (SAE) within 90 days;
- Access puncture complications;
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Successful rate of CAS
时间窗: 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%.
次要结局
- Procedure time(24 hours)
- Access puncture complications(90 days)
- Serious adverse events (SAE)(90 days)
研究者
Liu Sheng
Chief Physician
The First Affiliated Hospital with Nanjing Medical University