ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.
The secondary objective is to evaluate the safety and clinical performance of the studied devices.
详细描述
In this study patients will be observed, who receive a branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®) for the endovascular treatment of aortic arch pathologies with proximal landing at zone 0. The devices 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 branch stent graft systems for aortic arch (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®). Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.
The period of data collection will be approximately 60 months from the index procedure for each patient. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 and 90 years old
- •Patient with aortic arch pathologies (aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma), treated by branched stent-grafts (Nexus stent graft system©, Relay® Branch or Zenith arch branch graft®, with proximal landing at zone
- •Patient must be available for the appropriate follow-up times for the duration of the study
- •Informed consent signed.
排除标准
- •Patient less than 18 years old or more than 90 years old.
- •Patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium)
- •Patient has systemic infection or suspected systemic infection
- •Patient has thrombocytopenia (platelet count < 150000/µl)
- •Patient has untreated hyperthyroidism
- •Patient has a progressive or untreated malignancy.
- •Patient is pregnant or breastfeeding.
- •Patient has a life expectancy of less than 1 year.
- •Not informed consent signed
结局指标
主要结局
Mortality
时间窗: 30 days
Rate of all-cause mortality
次要结局
- Major Adverse Events (MAE)(prior to discharge, 30 days, 3-6, 12, 24, 36, 48, 60 months)
- Mortality(3-6, 12, 24, 36, 48, 60 months)
- Stable aneurysm size(30 days, 3-6, 12, 24, 36, 48, 60 months)
- Delivery time(Perioperative)
- Proximal intercomponent separation(30 days, 3-6, 12, 24, 36, 48, 60 months)
- Integrity(30 days, 3-6, 12, 24, 36, 48, 60 months)
- Secondary patency(30 days, 3-6, 12, 24, 36, 48, 60 months)
- Primary technical success(24 hours)
- Technical success(24 hours)
- Rupture(3-6, 12, 24, 36, 48, 60 months)
- Number of interventions(Perioperative)
- Reintervention(30 days, 3-6, 12, 24, 36, 48, 60 months)
- Endoleak(30 days, 3-6, 12, 24, 36, 48, 60 months)
- Clinical success(30 days, 3-6, 12, 24, 36, 48, 60 months)
- Primary patency(30 days, 3-6, 12, 24, 36, 48, 60 months)
- Infection(30 days, 3-6, 12, 24, 36, 48, 60 months)
- Primary clinical success(30 days, 3-6, 12, 24, 36, 48, 60 months)
- Decreasing(30 days, 3-6, 12, 24, 36, 48, 60 months)
- Increasing(30 days, 3-6, 12, 24, 36, 48, 60 months)
- Kinking(30 days, 3-6, 12, 24, 36, 48, 60 months)