A Prospective Randomized Study of Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percentage of Patients With Primary Graft Patency
研究概览
简要总结
The investigators propose a randomized study to compare bovine carotid artery (BCA) biologic grafts and expanded polytetrafluoroethylene grafts (ePTFE) for permanent hemodialysis access.
详细描述
Arteriovenous grafts (AVG) remain reliable substitutes for permanent hemodialysis access in scenarios that preclude the placement of arteriovenous fistulae. There is scarcity of evidence to support the current preference of synthetic conduits over biologic grafts in clinical practice. Advances in the design of AVG's warrant contemporary comparisons between synthetic and biologic AVG options. This is especially important as biologic conduits may confer an advantage by virtue of their inherent similarity to the native human vasculature.
The overall goal of this project is to compare one and two year patency (functional, primary, primary assisted and secondary), complication rates and re-intervention rates between BCA and standard ePTFE grafts. The investigators hypothesize that vascular patient who will receive the BCA graft will have improved patency as well as lower complication and re-intervention rates compared to the standard ePTFE graft.
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)
盲法说明
The study will not be blinded because patient side blinding is expected to have minimal to no effect, while physician side blinding is impractical; and difficult to achieve due to the primary surgeon being the one usually who follows up on any intervention or treatment.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 18 years of age
- •Have End Stage Renal Disease and are undergoing Arterio-Venous-Graft surgery
- •Not Eligible to receive an Arterio-Venous-Fistula
- •Provided written informed consent
- •Agreed to return for all required clinical follow up for the study
排除标准
- •Eligible to receive an Arterio-Venous-Fistula
- •Known allergic reaction or history of intolerance to any ePTFE or BCA components
- •Local infection at AVG placement site at the time of surgery
- •Patients with a bleeding disorder or who refuse blood transfusion
- •Patients with an active malignancy
- •Life expectancy less than 1 year
- •Pregnant women or those planning on becoming pregnant for the duration of the study
研究组 & 干预措施
Expanded polytetrafluoroethylene (ePTFE)
The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.
干预措施: Expanded polytetrafluoroethylene Graft (Device)
Bovine carotid Artery Graft
The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.
干预措施: Bovine Carotid Artery Graft (Device)
结局指标
主要结局
Percentage of Patients With Primary Graft Patency
时间窗: Two years after Graft Placement
Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).
Percentage of Patients With Primary-Assisted Graft Patency
时间窗: Two years after Graft Placement
Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.
Percentage of Patients With Secondary Graft Patency
时间窗: Two years after Graft Placement
Secondary patency is defined as the interval from graft placement to graft failure.
Percentage of Patients With Functional Patency
时间窗: Two years after Graft Placement
Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)
次要结局
- Incidence of Pseudoaneurysms Formation at the Access Site(At 24 months after Graft Placement)
- Percentage of Patients With Surgical Site Infection(At 24 months after Graft Placement)
- Steal Syndrome(At 24 months after Graft Placement)
- Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft(At 24 months after Graft Placement)