NCT04898153进行中（未招募）不适用
First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess)
Xeltis6 个研究点 分布在 4 个国家目标入组 20 人开始时间: 2021年6月10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
- 20
- 试验地点
- 6
- 主要终点
- Freedom from device related serious adverse events
研究概览
简要总结
A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.
详细描述
A prospective, single arm, non-randomized FIH feasibility study to evaluate the preliminary 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, and are deemed not suitable for fistula creation by the operating 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 older than 18 years with end-stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of an autogenous AV fistula, and therefore require placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy
- •Suitable anatomy 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 (NHYA Functional Class IV and/or EF <30%), myocardial infarction within six months of study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- •Stroke within six months before study entry
- •Active clinically significant autoimmune / inflammatory disease, immunodeficiency (including AIDS / HIV), use of immunosuppressive therapy or medication that likely interferes with restorative therapies
- •Abnormal blood values (e.g. leurkopenia with white blood cell (WBC) count < 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
- •Any active local or systemic infection (WBC > 15,000/mm3)
- •Uncontrolled or poorly controlled diabetes (hemoglovin A1c > 8% despite standard care) or hospitalization for poor glucose control within the previous 6 months
- •Reduced liver function, defined as: >2x the upper limit of normal for serum bilirubin, aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase; International Normalized Ratio (INR) > 1.5 or prothrombin time (PT) > 18 seconds
- •Known heparin-induced thrombocytopenia
- •Active bleeding disorder and/or any coagulopathy or thrombo embolic disease
- •History or evidence of severe peripheral vascular disease in the upper limbs
- •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
- •More than 1 failed dialysis access graft in the operative limb
- •Anticipated renal transplant within 6 months
- •Subjects receiving a forearm graft which crosses the elbow
- •Allergies to study device (Nitinol) or agents/medication, such as contrast agents, aspirin, or clopidogrel, that cant be controlled medically
- •Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- •Subject is participating in another study
- •Previous enrollment in this study
- •Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and efficacy of the study conduit
结局指标
主要结局
Freedom from device related serious adverse events
时间窗: 6 months
The number of patients who have a device related serious adverse event
Functional patency of graft
时间窗: 6 months
The number of patients with a functionally patent graft
次要结局
- Time to loss of patency (primary, primary assisted, and secondary)(6, 12, 18, 24, and 60 months)
- Proportion of hemodialysis (HD) sessions completed via central venous catheter(12 months)
- Functional patency of graft(12, 18, 24, and 60 months)
- Freedom from device related serious adverse events(12, 18, 24, and 60 months)
- Patency (primary, primary assisted, and secondary) of graft(6, 12, 18, 24, and 60 months)
- Time to potential central venous catheter removal(Assessed retrospectively at 30 days)
- Rate of access site infections(6, 12, and 24 months)
- Pseudoaneurysm formation(6, 12, and 24 months)
- Rate of access related interventions required to achieve/maintain patency(6, 12, and 24 months)
- Number of days with central venous catheter in place (catheter contact time)(12 months)
研究者
研究点 (6)
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相关资讯
Xeltis' aXess Receives FDA Breakthrough Device Designation and Enrolls First Patient in Pivotal Trial• Xeltis' aXess, a synthetic vascular access device, has been granted Breakthrough Device designation by the FDA, expediting its path to market.
• The pivotal trial, a prospective, single-arm, multi-center study, is evaluating the safety and performance of aXess in adults with end-stage renal disease needing dialysis.
• aXess is designed to transform into a living blood vessel, potentially reducing infection and reintervention rates compared to existing arteriovenous grafts.
• Positive 12-month data from a European first-in-human trial showed 100% secondary patency and 78% primary assisted patency, indicating promising initial results.last yearXeltis' aXess Receives FDA Breakthrough Device Designation and Enrolls First Patient in Pivotal Trial• Xeltis' aXess, a synthetic vascular access device, has been granted Breakthrough Device designation by the FDA, expediting its path to market through prioritized review and enhanced interaction with FDA experts.
• The company has enrolled and treated the first patient in its US pivotal trial, a prospective, single-arm, multi-center study evaluating the safety and performance of aXess in adults with end-stage renal disease needing dialysis.
• aXess is designed to transform into a living blood vessel, potentially reducing infection and reintervention rates compared to existing arteriovenous grafts, offering an improved vascular access option for unsuitable fistula patients.
• Positive 12-month data from a first-in-human European trial showed 100% secondary patency and 78% primary assisted patency, indicating promising outcomes for the novel vascular access conduit.last yearXeltis' aXess Conduit Shows Promising 12-Month Results in Hemodialysis Access• Xeltis announced positive 12-month data from its first-in-human trial of aXess, a hemodialysis vascular conduit, presented at VEITHsymposium 2023.
• The trial data showed 100% secondary patency and 78% primary assisted patency with no infections observed in 20 patients.
• aXess is designed to create a new, living vessel for hemodialysis access, potentially reducing interventions and infections compared to current standards.
• A pivotal trial is underway, enrolling up to 110 patients across nine EU countries to further evaluate aXess.2 years ago