NCT05636527招募中不适用
A Non-Randomized, Prospective or Retrospective, Open-Label, Multi-Center, Observational Clinical Study With Two Arms to Further Evaluate Safety and Performance of the NEXUS® Aortic Arch Stent Graft System and the Custom-Made NEXUS Multibranch™ Aortic Arch Stent Graft System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 18
- 主要终点
- Mortality
研究概览
简要总结
The goal of this observational study is to collect clinical information on how safe, and how well the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System work for the treatment of aortic aneurysms, in the standard-of-care setting.
The main question[s] it aims to answer are:
- Early mortality
- Safety outcomes throughout the study
- Device failure throughout the study
- Procedural and hospitalisation information Participants will be treated per institutional standard of care Follow-up information will be collected through to five years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mortality
时间窗: 30 days
The primary outcome in this study is early mortality, defined as lesion related death or any death that occurs within 30-days post-procedure or within initial hospitalization following the index procedure (whichever occurs last), unless there is evidence of accidental or self-inflicted death
次要结局
- Device failure(Procedure, 30 days, 12 months)
- Major Adverse Event (MAE)(30 days and 12 months)
- Mortality(12 months)
研究者
研究点 (18)
Loading locations...
相似试验
已完成
不适用
Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF)Atrial FibrillationNCT02168972Kardium Inc.60
招募中
不适用
Non-randomized Observational Study to Evaluate ReX® in the Management of Solid Oral Medication.Any Solid Oral MedicationNCT06335758Dosentrx Ltd.1,000
已完成
不适用
Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral RectopexyRectal ProlapseNCT04130555Meccellis Biotech55
终止
不适用
A Clinical Investigation of the Oxford® Partial Knee SystemOsteoarthritisNCT00699257Biomet Orthopedics, LLC85
已完成
不适用
A Clinical Investigation of the Balance® Microplasty™ Hip SystemOsteoarthritis, HipRheumatoid ArthritisAvascular NecrosisNCT00699088Biomet Orthopedics, LLC70
