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临床试验/DRKS00016666
DRKS00016666已完成不适用

An observational multicentre study to confirm the safety and performance of the BeGraft Peripheral Stent Graft System (BGP) in renal arteries - BGP-2, BGP in renal arteries

Bentley InnoMed GmbH0 个研究点目标入组 32 人开始时间: 2019年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
one 至 one(—)
性别
All

入选标准

  • Patients with an indication for intraluminal chronic placement of a BeGraft Peripheral Stent Graft System in renal arteries or patients who have already received a BeGraft Peripheral Stent Graft System can be included if:
  • The treatment is for restoring and improving the patency or treating aneurysms, acute perforations, acute ruptures or fistulas
  • They have a signed data privacy consent
  • Criteria for renal interventions is given according to relevant guidelines

排除标准

  • Patients with any contraindication according to the IFU (instructions for use)
  • Intolerance to antiplatelet therapy
  • Lytic agent administered in the past 30 days
  • History of bleeding diathesis
  • Coagulopathy
  • Gastrointestinal hemorrhage within the past 6 months
  • Life expectancy less than 1 year
  • Dialytic patients
  • BGP is used in combination with an EVAR/S device for the treatment of an aorta aneurysm
  • BGP as a bridging stent

研究者

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