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

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

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.

Study Overview

Status

Recruiting

Conditions

Femoral; Aneurysm

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yann GOUEFFIC, MD, PhD
Phone Number: +33 144126172
Email: ygoueffic@ghpsj.fr

Study Locations

France
- - Paris, France, 75014
    - Recruiting
    - Groupe Hospitalier Paris Saint-Joseph
    - Contact:
      
      Yann GOUEFFIC
      
      Phone Number: 0144126172
      
      Email: ygoueffic@ghpsj.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

These patients were or are referred for a post puncture false femoral aneurysm between 01/09/2020 and 31/12/2022.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy at 1 month of thrombin injection Time Frame: Month 1	This outcome corresponds to the percentage of false aneurysm thrombosis at 1 month.	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative effectiveness of thrombin injection Time Frame: Year 1	This outcome corresponds to the number of intraoperative false aneurysm thrombosis and the number of false aneurysm thrombosis at 12 months.	Year 1
Re-intervention Time Frame: Year 1	This outcome corresponds to the number of no re-intervention at the target lesion at 1 and 12 months.	Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 1, 2022

First Submitted That Met QC Criteria