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临床试验/NCT05233670
NCT05233670招募中不适用

Percutaneous Treatment of Iatrogenic False Femoral Aneurysms by Ultrasound-guided Thrombin Injection

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Efficacy at 1 month of thrombin injection

研究概览

简要总结

Since the 2000s, endovascular procedures have been expanding rapidly in multiple disciplines: cardiology, radiology, interventional neuroradiology, and of course vascular surgery. Most procedures are performed by puncture of the common femoral artery with introducers ranging in size from 4F to 26F for aortic procedures.

The most frequent complications of percutaneous punctures are false femoral aneurysms due to failure to close the arterial gap (up to 8% in some studies). A false aneurysm is a pocket of blood communicating with an artery and secondary to the rupture of the arterial wall. The blood is then contained by the adjacent structures and often a fibrous shell which distinguishes it from an aneurysm which retains the integrity of its wall.

The management of false femoral aneurysms is variable. Below 2 cm, monitoring may be performed with or without manual or ultrasound-guided compression. In case of persistence of the false aneurysm and/or complication, open surgery can be performed.

Endovascular treatment of false aneurysms was first proposed in 1986. Different endovascular techniques can be proposed to occlude false aneurysms such as the use of coils, biological glue, the use of arterial closure systems...

Echoguided injection of thrombin to occlude the false aneurysm in a manner has been published since the late 1990s. The treatment is evaluated as reliable and safe. A recent article in the EJVES (6) investigates the value of low-dose thrombin for this indication, and the results appear to be very encouraging for low-dose thrombin in false femoral aneurysms.

Thrombin injection for the treatment of iatrogenic false femoral aneurysms is the technique currently favoured by the vascular surgery team at the Paris Saint Joseph Hospital Group (GHPSJ). Open surgery is a second-line treatment and remains indicated in case of acute symptoms (radiculalgia, motor/sensory deficits; ischemia, skin necrosis), a false aneurysm that is too deep or without a neck, an infectious origin or a patient treated with dabigatran. Patients will be reviewed at 1 and 12 months according to the usual follow-up.

In this work, investigators will study the efficacy of false aneurysm closure using human thrombin injection. This work is intended to confirm previous work. A socio-economic study may be conducted in parallel. Follow-up after the use of percutaneous closure systems and in the context of bypass surgery may also be of interest.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Patient whose age ≥ 18 years
  • Patient with iatrogenic false femoral arterial aneurysm, post arterial or venous puncture, following management for a diagnostic or therapeutic examination.
  • Circulating false aneurysm confirmed by an imaging examination (echo-Doppler, angioscanner; angio-MRI).
  • Indication for exclusion of false aneurysm
  • False aneurysm treated at GHPSJ between 01/09/2020 and 31/12/2022 by thrombin injection

排除标准

  • Patient under guardianship or curatorship
  • Patient under court protection
  • Patient objecting to the use of his/her data for this research

结局指标

主要结局

Efficacy at 1 month of thrombin injection

时间窗: Month 1

This outcome corresponds to the percentage of false aneurysm thrombosis at 1 month.

次要结局

  • Intraoperative effectiveness of thrombin injection(Year 1)
  • Re-intervention(Year 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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