EndoForce Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The goal of this observational study is to collect long-term safety and performance data for the use of the EndoForce System for connecting a hemodialysis graft to a vein in patients with End Stage Renal Disease. This is not an experimental procedure or an experimental therapy. This means that the study device has been approved by the FDA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient is ≥18 years of age.
- •Patient requires the creation of a vascular access graft for hemodialysis, secondary to a diagnosis of ESRD.
- •Patient is able to have the vascular access ePTFE graft placed in an upper arm.
- •Patient or his/her legal guardian understands the study and is willing and able to comply with the dialysis schedule and follow-up requirements.
- •Patient or his/her legal guardian provides written informed consent.
排除标准
- •All contraindications for the EndoForce Connector System according to the IFU.
- •Patient is pregnant.
- •Patient is enrolled in another dialysis or vascular investigational study, without prior approval from the Sponsor.
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 2 years
All device and/or procedure-related events and all major adverse events that reasonably suggest the involvement of the EndoForce and that require or result in any of the following: death, emergent surgery, events requiring hospitalization, events requiring percutaneous interventions, vascular access infection requiring treatment, significant bleeding, pseudoaneurysm and serious adverse events. EndoForce migration, inadequate seal and leakage will also be collected acutely and at each in-person follow-up visit.
AVG Cumulative Patency
时间窗: 2 years
The percentage of subjects free from loss of access of the study graft for hemodialysis.
Number of AVG Interventions to Maintain Patency
时间窗: 2 years
The number of AVG interventions until access abandonment or through study completion.
AVG Primary Patency
时间窗: 2 years
The percentage of subjects free from the first occurrence of either access thrombosis or an access procedure performed to maintain access patency.
Number of Participants with Acute Device Success
时间窗: Through end of procedure
AV graft flow at the end of the procedure as determined by palpable graft thrill and/or audible bruit, without significant bleeding or emergent surgery.
次要结局
未报告次要终点