Observational Prospective Post-Market Clinical Follow-Up (PMCF) Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 8
- 主要终点
- Primary Safety Endpoint. Number of subjects free from device-related infection at 24 months from device implant.
研究概览
简要总结
The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are:
- Safety: Freedom from device-related infection adverse events at 24 months from device implant
- Performance: Secondary patency at 24 months from device implant.
Participants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the device.
详细描述
This is a European, Observational, Non-Interventional, Prospective, Non-Randomized, Single Arm, Multicenter, PMCF Registry to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. There is no comparator device.
The aim of study is to obtain real-world observational evidence about the use of the device.
The AVG 22-09 registry consists of End-Stage Renal Disease (ESRD) patients who require hemodialysis access through Vascular Graft per the evaluating physician.
A total of 72 subjects will be implanted in this registry with a limit of 25 subjects implanted per site.
The registry has been designed with standard eligibility criteria to enroll subjects for which the registry device is intended to treat. Only patients who meet all of the inclusion criteria and none of the exclusion criteria will be implanted. All patients must provide informed consent prior to any registry related procedures being performed and the patient is considered enrolled when informed consent is obtained.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease and intends to use GORE® ACUSEAL Vascular Graft device for arteriovenous (AV) access.
- •Age ≥18 years at time of Informed Consent Form (ICF) signature.
- •Willingness of the patient to adhere to institutional standard of care follow-up.
- •Informed Consent Form (ICF) is signed by the patient.
- •The patient is currently on hemodialysis or intended to begin hemodialysis immediately following placement of the GORE® ACUSEAL Vascular Graft device or up to 30 days following placement of the device.
- •The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
排除标准
- •The patient currently has a known or suspected systemic infection.
- •The patient is pregnant or breastfeeding.
- •The patient had a separate interventional or surgical vascular procedure within the study limb within 30 days prior to treatment with the GORE® ACUSEAL Vascular Graft device.
- •The patient had a previous documented (via imaging technique) and unsuccessfully treated ipsilateral central venous stenosis.
- •The patient is currently taking maintenance corticosteroids and immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (> 10 mg), cyclosporine, tacrolimus, or cyclophosphamide.
- •The patient has a known hypercoagulability or bleeding disorder.
- •The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to Heparin.
- •The patient is enrolled in an investigational study.
- •The patient has been previously enrolled in this registry.
- •The patient is currently being considered for a live donor kidney transplant (living donor either related or unrelated to patient).
- •The patient has life expectancy less than 2 years.
研究组 & 干预措施
ESRD patients that require hemodialysis access through the GORE® ACUSEAL Vascular Graft.
Patient population - patients with CKD in ESRD that require hemodialysis access through the GORE® ACUSEAL Vascular Graft.
Registry subject population - those patients with CKD in ESRD that require hemodialysis access through the GORE® ACUSEAL Vascular Graft meeting the inclusion and exclusion criteria will be eligible for screening for participation in this registry.
The registry has been designed with broad eligibility criteria to capture real-world GORE® ACUSEAL Vascular Graft use, for which the device is intended to be implanted. Only patients who meet all of the inclusion criteria and none of the exclusion criteria will be implanted.
No vulnerable populations are included in this registry.
干预措施: GORE® ACUSEAL Vascular Graft (Device)
结局指标
主要结局
Primary Safety Endpoint. Number of subjects free from device-related infection at 24 months from device implant.
时间窗: 24 months from device implant
Events will be computed as follows: 1. All subjects who had a registry device related AE with an Infection MedDRA code within 730 days from device implant will be tabulated as 'Not Free from Infection'. 2. All subjects who completed the registry and were infection free at 24 months from the registry procedure will be considered free from device related infection. All relevant infection MedDRA terms will be agreed upon by the Office of Medical Affairs within Gore. This endpoint will be treated as a patient-based binomial proportion, and no formal hypothesis will be tested. A Kaplan Meir analysis will also be done to account for censoring.
Primary Performance Endpoint. Secondary Patency at 24 months: The time from device implant to complete abandonment of the access site for hemodialysis regardless of the number of interventions required to restore or maintain patency.
时间窗: 24 months from device implant
Events will be computed as follows: 1. All subjects who have an abandonment or explant of the registry graft within 730 days will have lost secondary patency. The date will be noted on the discontinuation form. 2. All subjects who completed the registry within 730 days without a graft abandonment will be considered patent. 3. If a subject did not complete the registry for a reason other than graft abandonment or explant, they will be censored. A Kaplan Meir analysis will be done to account for censoring.
次要结局
- Secondary Patency at 6 and 12 months: The time from device implant to complete abandonment of the access site for hemodialysis regardless of the number of interventions required to restore or maintain patency.(6 and 12 months from device implant.)
- Primary patency at 6, 12 and 24 months from device implant. Time interval of uninterrupted patency from device implant to the next access thrombosis or intervention.(6, 12 and 24 months from device implant.)
- Percentage of Subjects free from bleeding events through 6, 12, and 24 months from device implant.(6, 12, and 24 months from device implant)
- Percentage of GORE® ACUSEAL Vascular Grafts cannulated within 1, 2, 3, 7, and 14 days from device implant.(Cannulation within 1, 2, 3, 7 and 14 days from device implant.)