NCT00448708终止不适用
Trial to Assess the Effectiveness of Maintaining Patency and Safety of the Vascular Wrap Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® ePTFE Vascular Graft in the Upper Extremity for Hemodialysis Vascular Access
Angiotech Pharmaceuticals65 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 222
- 试验地点
- 65
- 主要终点
- Time-to-loss of Target Site Primary Patency
研究概览
简要总结
This is a multi-center clinical study in subjects requiring arteriovenous grafts in the upper extremity for hemodialysis access. All subjects will provide informed consent before undergoing any study procedures. The study will consist of multiple subject visits and telephone contacts during the 52 week study period. During the study period subjects must also maintain an appropriate hemodialysis schedule.
IDE Number: G060250
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 (Participant)
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
- •be ≥ 18 years of age;
- •if female of childbearing potential, provide evidence of a negative pregnancy test within 3 days prior to graft placement (Day -3 to Day 0);
- •be a candidate for a new end-to-side arteriovenous anastomosis graft placed in the upper extremity;
- •have an outflow vein of greater than or equal to 3 mm in diameter;
- •be able to effectively communicate with study personnel;
- •be considered by the physician to be available for subsequent visits;
- •be willing to comply with all aspects of the treatment and evaluation schedule over a 52 week duration;
- •allow representatives of the sponsor, designated CRO, Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records;
- •sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures;
- •must agree to participate in protocol 014-VWAV07, a safety study to run consecutively for an additional 4 years or until Post-Market Approval (PMA), whichever is longer; and
- •have the Lifespan® ePTFE Vascular Graft successfully implanted.
排除标准
- •pregnant, breast-feeding, or female of childbearing potential who do not agree to remain abstinent or to use a contraceptive method during the study period. Non-childbearing potential is defined as either post-menopausal (amenorrheic for at least 1 year) or surgically sterile. Surgically sterile is defined as tubal ligation or the absence of the uterus and/or ovaries;
- •male of childbearing potential, who does not agree to remain abstinent or to use contraception to prevent fathering a child during the course of the study. Non-childbearing potential is defined as vasectomy or bilateral orchiectomy;
- •a central venous stenosis on the ipsilateral side is documented;
- •a hypercoagulable state is documented;
- •life expectancy is less than one year;
- •an organ transplant is expected within 6 months of test or control product (study products) placement;
- •hypersensitivity to any component of the study products or procedural materials or medications is known;
- •concurrently involved in another investigational study;
- •a study product being investigated by others has been received within 30 days prior to randomization in this trial;
- •the study product being studied in this trial has previously been received;
- •uncontrolled hypertension with systolic BP >200mmHg or diastolic BP >115mmHg is present at screening;
- •currently receiving chemotherapy or radiation therapy; or
- •placement of a new end-to-end arteriovenous anastomosis graft is required.
结局指标
主要结局
Time-to-loss of Target Site Primary Patency
时间窗: 1 year
Subjects had primary patency at the target site from graft placement until an intervention on the target site occurred. The duration between graft implantation and graft abandonment due to loss of patency at the target site was the "time-to-loss of primary patency." Note: The study was halted early and therefore became underpowered to analyze efficacy as detailed in the protocol.
次要结局
- Adverse Events(1 year)
研究者
研究点 (65)
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