Random, Controlled, Single-blinded, Multi-center and Non-inferiority Clinical Study to Evaluate Safety and Effectiveness of XenoSure® Biological Patch in the Application of Peripheral Vascular Repair
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Primary patency measured by ultrasound
研究概览
简要总结
The purpose of this trial is to collect safety and effectiveness data to support peripheral vascular indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulation in this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.
详细描述
The purpose of this trial is to collect safety and effectiveness data to support peripheral vascular indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulation in this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.
144 subjects for peripheral vascular repair, including respective 72 subjects for the trial group and the control group.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any man or woman aged between 18~80 years old 2) The expected lifetime of no less than 12 months 3) The subject can be considered for suturing with XenoSure Biological Patch after the peripheral vascular repair surgery. The subject's targeted arterial diameter is less than 5mm or the arterial incision length is more than 4cm and less than 9cm.
- •Physical conditions and vital signs meet requirements for the surgery. 5) The subjects and/or their guardians sign the written Informed Consent Form.
排除标准
- •Patients with severe visceral diseases in heart, liver, kidney, etc.
- •Patients have unstable vital signs and not suitable for the surgery indications
- •Patients need vascular outflow stenting repair in the same location with XenoSure® Biological Patch.
- •Pregnant or lactating women
- •Patients With severe allergic history (especially allergic to bovine materials)
- •Patients with the past medical history of severe immunodeficiency disease
- •The subject has used or plans to use immunomodulatory drugs for more than half a year.
- •The subject with poor blood clotting function is defined as that pre-operative INR or APTT is prolonged over 30% than the reference value without drug intervention, or that blood platelet count is less than 100*10^9/L.
- •The subject has severe kidney disorders or diseases with the estimated glomerular filtration rate [GRF]<30mL/min/1.73m
- •The subject's ALT or AST level is 2.5 times higher than the upper normal limit or the subject has active liver disease or icterus.
- •The subject has participated in another clinical study within 3 months or is participating in another clinical study now.
- •The investigator believes that the subject has other reasons unsuitable for inclusion.
研究组 & 干预措施
Test Arm
Test Arm are subjects to be implanted with test article -XenoSure patch. The interventions include: Repair/reconstruction of the diseased vessel; Implant the XenoSure patch
干预措施: Implant the XenoSure patch (Device)
Test Arm
Test Arm are subjects to be implanted with test article -XenoSure patch. The interventions include: Repair/reconstruction of the diseased vessel; Implant the XenoSure patch
干预措施: Repair/reconstruction of the diseased vessel (Procedure)
Control Arm
Test Arm are subjects to be implanted with B. Braun's Vascular-Patch.The interventions include: Repair/reconstruction of the diseased vessel; Implant the Vascular-Patch.
干预措施: Repair/reconstruction of the diseased vessel (Procedure)
Control Arm
Test Arm are subjects to be implanted with B. Braun's Vascular-Patch.The interventions include: Repair/reconstruction of the diseased vessel; Implant the Vascular-Patch.
干预措施: Implant the Vascular-Patch (Device)
结局指标
主要结局
Primary patency measured by ultrasound
时间窗: 6 months
The treated vessel is considered "patent" if the re-narrowing of the ID of the vessel is less than 20% of the ID that measured immediately after procedure. The study is considered achieved its primary endpoint if the primary patency rate of test device is non-inferior to the rate of the comparator device.
次要结局
未报告次要终点