Fluoroscopy Guided Femoral Arterial Access and the Use of Closure Devices: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 990
- 试验地点
- 4
- 主要终点
- Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm.
研究概览
简要总结
The purpose of this study is to compare the use of fluoroscopic guidance, (a commonly used X-ray technique), with the traditional approach, (where the doctors feel for the strongest pulse), to obtain access to the blood vessel in the groin. These two methods are being compared to assess which is faster, safer and more often allows your physician to use an "arterial closure device," a small suture or plug applied at the end of the angiogram where the needle enters your blood vessel if he/she chooses.
详细描述
Design: A prospective, randomized, controlled clinical trial to study the effectiveness of applying fluoroscopy guided femoral artery access in the cardiac catheterization lab and its effect on the usage of FDA approved femoral artery closure devices. This trial will randomize patients between fluoroscopy guided femoral artery access or femoral artery access using the usual anatomic landmarks and will then study the difference in the ability to use closure devices on the access site.
Purpose: To establish the safety and efficacy of using fluoroscopic assistance to allow access of the common femoral artery rather than its branches and thus increase the ability to use closure devices.
Enrollment: An approximate enrollment of up to 1000 patients (all patients randomized) who will be undergoing cardiac catheterization and who meet all the eligibility criteria at OUMC and VAMC in Oklahoma City.
Duration: The study will be conducted over approximately one year.
Primary Endpoint: Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm.
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
- None
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
- •Age 18 and over.
- •Patients undergoing elective or urgent left heart cath from the femoral approach.
- •Willingness to participate and sign the consent form.
排除标准
- •Access from site other than the common femoral artery.
- •Creatinine >= 3.0mg/dl.
- •Graft in the common femoral artery or other surgeries at that site that might have changed the anatomy of the groin.
- •Unable or refusal to sign a consent form.
- •Patients from the Department of Corrections.
- •Pregnant Women
- •Undetectable femoral artery pulse.
- •Patients undergoing emergent cardiac catheterization for ST elevation MI or unstable ACS.
结局指标
主要结局
Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm.
时间窗: 24 hours
次要结局
- Compare the incidence of known major side effects of femoral artery puncture between the two methods of access(24 hours)
- Compare the time and number of attempts needed to obtain arterial access between the two groups of patients.(Intraprocedural)
- Compare the ability to puncture the common femoral artery using fluoroscopy vs. anatomical landmarks among different levels of trainees (cardiology fellows) and attending cardiologists.(Intraprocedural)
- Assess whether fluoroscopic guidance is a superior method to obtain access and thus should be used as a training technique for cardiology fellows.(End of study analysis)