NCT05473299进行中（未招募）不适用
Prospective, Non-randomized Pivotal Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft: aXess Pivotal Study
Xeltis22 个研究点 分布在 9 个国家目标入组 120 人开始时间: 2022年11月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 22
- 主要终点
- Freedom from device-related SAE during the first 6 months
研究概览
简要总结
A prospective, single arm, non-randomized pivotal study to evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.
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
- •Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start or maintain hemodialysis therapy
- •At least 18 years of age at screening
- •Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess graft
- •The patient, or legal representative, has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent
- •The patient has been informed and agrees to pre- and post- procedure follow-up
- •Life expectancy of at least 12 months
排除标准
- •History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF <25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- •Uncontrolled or poorly controlled diabetes
- •Abnormal blood values that could influence patient recovery and or/ graft hemostasis
- •Reduced liver function, defined as: >2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) >1.5 or prothrombin time (PT) >18 seconds
- •Any active local or systemic infection
- •Known heparin-induced thrombocytopenia
- •Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
- •Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
- •Anticipated renal transplant within 6 months
- •Known or suspected central vein obstruction on the side of planned graft implantation
- •Previous dialysis access graft in the operative limb unless the aXess graft can be placed more proximally than the previous failed graft
- •Previous enrolment in this study
- •Subject is participating in another study
- •Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- •Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit
- •Intra-operative exclusion criteria:
- •Unsuitable anatomy to implant the aXess graft (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)
结局指标
主要结局
Freedom from device-related SAE during the first 6 months
时间窗: up to 6 months
Primary patency rate
时间窗: 6 months
Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
次要结局
- Implantation success rate(1 day, from moment of implant until end of procedure day)
- Rate of access-related interventions required to achieve/maintain patency(6, 12, 18, 24, and 60 months)
- Following first cannulation, number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment(12 months)
- Freedom from device-related SAE(12, 18, 24, and 60 months)
- Rate of access site infections(6, 12, 18, 24, and 60 months)
- Time (expressed in months) to first intervention and to access abandonment(60 months)
- Patency (primary, primary assisted, secondary, and functional) rates(6, 12, 18, 24 and 60 months)
- Proportion of hemodialysis sessions completed via central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment(12 months)
- Time to first cannulation(12 months)
研究者
研究点 (22)
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