Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 140
- 试验地点
- 12
- 主要终点
- Secondary patency rate in survivors
研究概览
简要总结
A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.
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 (within the first 6 months of follow-up) or maintain hemodialysis therapy and are deemed unsuitable for fistula creation by the investigational surgeon.
- •At least 18 years of age at screening.
- •Suitable anatomy (e.g. a target vein with a minimum diameter of 4mm) for the implantation of an aXess graft
- •The patient 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 6 months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina.
- •Uncontrolled or poorly controlled diabetes in the opinion of the investigator. Recommended standards of A1c level <8% / 183 mg/dl / 10.2 eAG.
- •Abnormal blood values (e.g., leukopenia with white blood cell count (WBC) <4,000/mm³ and/or anemia with Hemoglobin <8g/dL and/or thrombocytopenia <100,000/mm³) 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 previously failed graft.
- •Previous enrollment in this study.
- •Subject is participating in another study.
- •A female who is breastfeeding or of childbearing potential with a positive pregnancy test or not using adequate contraception.
- •Any other condition which, in the judgment of the investigator, would preclude adequate evaluation for the safety and performance of the study conduit.
- •Intra-operative exclusion criteria:
- •1. Unsuitable anatomy to implant the aXess graft (e.g., target vein and/or artery diameter not suitable; severe calcification).
研究组 & 干预措施
aXess graft
干预措施: Xeltis Hemodialysis Access (aXess) graft (Device)
结局指标
主要结局
Secondary patency rate in survivors
时间窗: 12 months
Secondary patency is defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain or restore the vascular access's functionality. Patients who died or changed dialysis modality before 12 months will be excluded from the primary effectiveness analysis if loss of secondary patency was not observed before these events
Rate of device related infections and bleeding
时间窗: 12 months
Infections are defined as: All device or procedure related infections potentially resulting from surgical manipulations or device cannulation, including both minor and major infections., Bleeding (procedure or device related bleeding, at least BARC 2) and device related hematoma defined as blood accumulation around the graft arising from the implantation or cannulation that triggered a medical or surgical action
次要结局
- Rate of access-related interventions required to achieve/maintain patency(6, 12, 18, 24, 60 months)
- Implantation success rate(1 day, from moment of implant until discharge)
- Time to the first cannulation(12 months)
- Following the first cannulation, the 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(Discharge, 1, 3, 6, 12, 18, 24, and 60 months)
- Incidence rate of access site infections(6, 12, 18, 24, and 60 months)
- Proportion of hemodialysis sessions completed via a central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment(12 months)
- Rate of peri-reintervention vascular injuries(6 months)
- Patency (primary, primary assisted, secondary, and functional) rates(6, 12, 18, 24, and 60 months)
- Time to first intervention and to access abandonment(60 months)