Femoral; AneurysmEGTINCT05233670
Percutaneous Treatment of Iatrogenic False Femoral Aneurysms by Ultrasound-guided Thrombin Injection
An observational study of Femoral; Aneurysm, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Since the 2000s, endovascular procedures have been expanding rapidly in multiple disciplines: cardiology, radiology, interventional neuroradiology, and of course vascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral; Aneurysm
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: These patients were or are referred for a post puncture false femoral aneurysm between 01/09/2020 and 31/12/2022.
Who may be able to join
- 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
Who cannot join
- Patient under guardianship or curatorship
- Patient under court protection
- Patient objecting to the use of his/her data for this research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
Yann GOUEFFIC, 0144126172, ygoueffic@ghpsj.fr
About this study
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.
Read more
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.
- Conditions
- Femoral; Aneurysm
- Medical subject headings
- Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy at 1 month of thrombin injection
This outcome corresponds to the percentage of false aneurysm thrombosis at 1 month.
Measured: Month 1
Secondary outcomes (2)
Intraoperative effectiveness of thrombin injection
This outcome corresponds to the number of intraoperative false aneurysm thrombosis and the number of false aneurysm thrombosis at 12 months.
Measured: Year 1
Re-intervention
This outcome corresponds to the number of no re-intervention at the target lesion at 1 and 12 months.
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Dec 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Femoral; AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yann GOUEFFIC, MD, PhD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233670
- Sponsor's protocol ID
- EGTI
- Acronym
- EGTI
- Status last verified
- Apr 2023
- First submitted
- 1 Feb 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boge G, Laroche JP, Alric P. [Treatment of post-catheterization pseudoaneurysms by ultrasound-guided thrombin injection: A single-center experience and practical guideline]. J Med Vasc. 2017 Jul;42(4):198-203. doi: 10.1016/j.jdmv.2017.05.003. Epub 2017 Jun 28. French.
PubMed 28705337Gummerer M, Kummann M, Gratl A, Haller D, Frech A, Klocker J, Fraedrich G, Gruber H. Ultrasound-Guided Fibrin Glue Injection for Treatment of Iatrogenic Femoral Pseudoaneurysms. Vasc Endovascular Surg. 2020 Aug;54(6):497-503. doi: 10.1177/1538574420934631. Epub 2020 Jun 19.
PubMed 32552570Cope C, Zeit R. Coagulation of aneurysms by direct percutaneous thrombin injection. AJR Am J Roentgenol. 1986 Aug;147(2):383-7. doi: 10.2214/ajr.147.2.383.
PubMed 3487958Liu W, Liu C, Lu SY. Percutaneous suture technique with ProGlide to manage vascular access pseudoaneurysm after percutaneous coronary intervention procedure: A case report. Chin J Traumatol. 2020 Feb;23(1):34-37. doi: 10.1016/j.cjtee.2019.11.002. Epub 2019 Dec 18.
PubMed 31956042Kang SS, Labropoulos N, Mansour MA, Baker WH. Percutaneous ultrasound guided thrombin injection: a new method for treating postcatheterization femoral pseudoaneurysms. J Vasc Surg. 1998 Jun;27(6):1032-8. doi: 10.1016/s0741-5214(98)70006-0.
PubMed 9652465Kurzawski J, Janion-Sadowska A, Zandecki L, Sadowski M. Comparison of the Efficacy and Safety of Two Dosing Protocols for Ultrasound Guided Thrombin Injection in Patients with Iatrogenic Femoral Pseudoaneurysms. Eur J Vasc Endovasc Surg. 2020 Jun;59(6):1019-1025. doi: 10.1016/j.ejvs.2020.01.009. Epub 2020 Feb 1.
PubMed 32014339
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Treatment of Iatrogenic False Femoral Aneurysms by Ultrasound-guided Thrombin Injection
- ClinicalTrials.gov ID
- NCT05233670
- Acronym / sponsor ID
- EGTI / EGTI
- Conditions
- Femoral; Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- These patients were or are referred for a post puncture false femoral aneurysm between 01/09/2020 and 31/12/2022.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patient under guardianship or curatorship
- Patient under court protection
- Patient objecting to the use of his/her data for this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy at 1 month of thrombin injection
Time frame: Month 1
This outcome corresponds to the percentage of false aneurysm thrombosis at 1 month.
2 secondary outcomes
Intraoperative effectiveness of thrombin injection
Time frame: Year 1
Re-intervention
Time frame: Year 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Background: PubMed 28705337Boge G, Laroche JP, Alric P. [Treatment of post-catheterization pseudoaneurysms by ultrasound-guided thrombin injection: A single-center experience and practical guideline]. J Med Vasc. 2017 Jul;42(4):198-203. doi: 10.1016/j.jdmv.2017.05.003. Epub 2017 Jun 28. French.
- Background: PubMed 32552570Gummerer M, Kummann M, Gratl A, Haller D, Frech A, Klocker J, Fraedrich G, Gruber H. Ultrasound-Guided Fibrin Glue Injection for Treatment of Iatrogenic Femoral Pseudoaneurysms. Vasc Endovascular Surg. 2020 Aug;54(6):497-503. doi: 10.1177/1538574420934631. Epub 2020 Jun 19.
- Background: PubMed 3487958Cope C, Zeit R. Coagulation of aneurysms by direct percutaneous thrombin injection. AJR Am J Roentgenol. 1986 Aug;147(2):383-7. doi: 10.2214/ajr.147.2.383.
- Background: PubMed 31956042Liu W, Liu C, Lu SY. Percutaneous suture technique with ProGlide to manage vascular access pseudoaneurysm after percutaneous coronary intervention procedure: A case report. Chin J Traumatol. 2020 Feb;23(1):34-37. doi: 10.1016/j.cjtee.2019.11.002. Epub 2019 Dec 18.
- Background: PubMed 9652465Kang SS, Labropoulos N, Mansour MA, Baker WH. Percutaneous ultrasound guided thrombin injection: a new method for treating postcatheterization femoral pseudoaneurysms. J Vasc Surg. 1998 Jun;27(6):1032-8. doi: 10.1016/s0741-5214(98)70006-0.
- Background: PubMed 32014339Kurzawski J, Janion-Sadowska A, Zandecki L, Sadowski M. Comparison of the Efficacy and Safety of Two Dosing Protocols for Ultrasound Guided Thrombin Injection in Patients with Iatrogenic Femoral Pseudoaneurysms. Eur J Vasc Endovasc Surg. 2020 Jun;59(6):1019-1025. doi: 10.1016/j.ejvs.2020.01.009. Epub 2020 Feb 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yann GOUEFFIC, MD, PhD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral; Aneurysm, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yann GOUEFFIC, MD, PhD (144126172 ext. +33, ygoueffic@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy at 1 month of thrombin injection (time frame: Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05233670, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.