Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL, AVG 08-06)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 主要终点
- Cumulative Patency at 6 Months
研究概览
简要总结
This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving or expected to require hemodialysis through a prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6 month cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other arteriovenous grafts (AVGs). > >>
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>> A total of 138 Subjects will be enrolled. Once the study procedure has been successfully completed, cannulation may occur at any time at the Investigator's discretion. >
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>> Subjects will be selected from up to 20 Investigational Sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient requires the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease. >
- •Patient is currently on hemodialysis or ready to begin hemodialysis within 30 days following placement of study device. > >>
- •The patient must be able to have the vascular access graft placed in an upper extremity. >
- •The patient is 18 years of age or older. >
- •The patient has a reasonable expectation of remaining on hemodialysis for 12 months. >
- •The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements. > >>
- •The patient or his/her legal guardian is willing to provide informed consent. >
排除标准
- •The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.>
- •The patient currently has a known or suspected systemic infection.>
- •The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.>
- •The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. >
- •The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.>
- •The patient is enrolled in another investigational study.>
- •The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.>
- •Study device is intended to be used temporarily.>
- •The patient has had >2 previous arteriovenous accesses in treatment arm.>
- •Patient is taking Aggrenox®.>
- •The patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.>
- •The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone(>10 mg), cyclosporine, tacrolimus or cyclophosphamide.>
- •The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.>
- •Life expectancy is less than 12 months.>
- •The patient is pregnant.>
- •The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).
结局指标
主要结局
Cumulative Patency at 6 Months
时间窗: 6 Months
Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.
Freedom From Bleeding at 6 Months
时间窗: 6 Months
Percentage of subjects free from both major and minor bleeding events, assessed at 6-months
次要结局
- Primary Unassisted Patency at 6 Months(6 Months)
- Time to Event Analysis (Cumulative Patency)(6 Months)
- Time to First Cannulation(Time of access placement to first cannulation, assessed up to one week)
- Time to Potential Central Venous Catheter Removal(Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123)