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临床试验/NCT05220540
NCT05220540已完成不适用

Retrospective Analysis of Balloon Expandable Covered Stenting in the Common Femoral Artery

Semmelweis University Heart and Vascular Center3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
3
主要终点
Reintervention rate

研究概览

简要总结

The aim of this study is to evaluate the safety and efficacy of balloon expandable covered stenting of access complications, stenoses or pseudoaneurysms of the common femoral access.

详细描述

In the past decades, there has been a paradigm shift in the field of vascular surgery, with endovascular interventions replacing traditional open surgical procedures on an increasing scale. Most of these interventions are performed via the femoral artery. Even with modern percutaneous vascular closure devices, interventional laboratories report a high incidence of vascular complications, most commonly bleeding. Interventional procedures are gaining ground as an alternative to surgery. Having regard to the fact that femoral arteries are in constant motion due to their location and are subject to intense bending forces, the long-term durability of stents has been questioned in the absence of long-term follow-up data. There is currently no broad consensus on the strategy of care for vascular complications, and overall the decision is left to the discretion of the interventionalist, largely determined by the available local resources and infrastructure. The use of covered stents is an option for endovascular treatment of the complications: the self expanding nitinol framed stent graft with polytetrafluoroethylene (PTFE) coating and the cobalt-chrome framed, also PTFE coated balloon expandable stent. The main aim of this research is to analyse the short- and long-term outcome of these alternatives.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • over 18 years of age
  • intervention from the left or right common femoral artery
  • access complication treated by balloon expandable covered stent(s) or common femoral artery disease treated by balloon-expandable covered stent(s)
  • Exclusion criteria:

排除标准

  • 未提供

结局指标

主要结局

Reintervention rate

时间窗: 1 year

Number of reinterventions on the treated vessels

Primary patency rate

时间窗: 1 year

Number of patent common femoral arteries at one year

Amputation rate

时间窗: 1 year

Number of amputations at the side of the treated common femoral artery

次要结局

  • Restenosis rate(1 year)
  • Walking disturbance rate(1 year)

研究者

发起方
Semmelweis University Heart and Vascular Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Csaba Csobay-Novák MD PhD

Head of Noninvasive Imaging

Semmelweis University Heart and Vascular Center

研究点 (3)

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