Prospective Multicenter Registry to Examine the Real-world Performance of the E-liac Stent Graft System for Treatment of Uni- or Bilateral Aorto-iliac or Iliac Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- JOTEC GmbH
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Freedom from endoleak type I or III and patency of EIA and IIA on E-liac implantation side(s)
研究概览
简要总结
The PLIANT II registry is undertaken to examine the real-world outcome after treatment of consecutive patients with uni- or bilateral aorto-iliac or iliac aneurysms using the E-liac Stent Graft System.
详细描述
In this study, patients will be observed who receive one or two E-liac Stent Graft(s) for aorto-iliac or iliac aneurysms. The E-liac Stent Graft(s) will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the E-liac Stent Graft System. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before intervention and before data are being collected.
The period of data collection will be 60 months starting from the intervention for each patient. 100% verification of patient informed consent and essential study documents will be performed at each study site. 60% of patient´s source documentation will be randomly monitored.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85 years
- •Patient must have an aorto-iliac or iliac aneurysm
- •Patient must have a unilateral or bilateral iliac aneurysm
- •Patient´s anatomy must be suitable for stent graft placement on preoperative angio CT scan
- •Patient must be available for the appropriate follow-up times for the duration of the study
- •Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to intervention
排除标准
- •Female of child bearing potential
- •Patients with ruptured iliac aneurysms
- •Patients with juxtarenal, pararenal or suprarenal aneurysms
- •Patients pretreated with Nellix (Endologix) or Altura (Lombard Medical)
- •Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- •Patient with malignancy needing chemotherapy or radiation
- •Patients with life expectancy of less than 3 years
- •Patient minor or under guardianship
结局指标
主要结局
Freedom from endoleak type I or III and patency of EIA and IIA on E-liac implantation side(s)
时间窗: 12 months
Rate of patients that reach the primary endpoint
次要结局
- Survival rate(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Aneurysm size(12, 24, 36, 60 months)
- Primary patency of EIA / IIA(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Endoleak type Ia in the CIA (isolated iliac aneurysm treatment)(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Claudication(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Secondary patency of EIA / IIA(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Endoleak type III(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Mortality(24 hours)
- Endoleak type I(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Endoleak type Ib in the IIA(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Adverse Events(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Stent graft dislodgement(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Endoleak type Ib in the CIA(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Endoleak type Ib in the EIA(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Endoleak type II(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Reintervention(prior to discharge / 30 days, 12, 24, 36, 60 months)
- Stent fracture(prior to discharge / 30 days, 12, 24, 36, 60 months)