NCT04250909已完成不适用
Retrospective 5-year Safety Analysis of the BIOLUX P-I and P-II Studies in Subjects Requiring Revascularization of Infrainguinal Arteries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biotronik AG
- 入组人数
- 132
- 试验地点
- 8
- 主要终点
- Overall survival
研究概览
简要总结
The aim is to collect long-term clinical data from 132 patients from Belgium, Germany and Austria who had previously participated in either of the BIOLUX P-I or P-II studies. Patients in these studies were treated with either a percutaneous transluminal angioplasty (PTA) balloon catheter or a drug-coated Passe-18-Lux balloon (DCB). The purpose of Retro-BIOLUX P-I-II is to collect clinical data from patients treated with either Passeo-18 PTA or Passeo-18 Lux DCB to analyze the long-term effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was previously enrolled in either BIOLUX P-I or BIOLUX P-II
- •Subject was treated either with Passeo-18 PTA or Passeo-18 LUX
- •Written informed consent by subject or subject's legal representative or impartial witness/waiver
排除标准
- •Subject did neither participate in BIOLUX P-I nor BIOLUX P-II
- •Subject was neither treated with Passeo-18 Lux nor with Passeo-18 PTA
- •Subject is not willing to sign an informed consent /data release form
结局指标
主要结局
Overall survival
时间窗: 60 months
Overall survival at five years after index procedure, defined as death from any cause
次要结局
- Major amputations of target extremities(60 months)
- Overall survival, defined as the time in days after index procedure to date of death from any cause.(60 months)
- Clinically-driven target lesion revascularization(60 months)
- Cause of death (descriptive analysis) at five years after treatment within BIOLUX P-I/-II.(60 months)
研究者
研究点 (8)
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