AtheromatousEversionNCT03357185
Prospective Evaluation of Femoral Tripod Eversion Technique
An observational study of Atheromatous, run by Hôpital NOVO at 1 site in France.
Trial summary
Endarteriectomy is considered as the first line treatment of femoral bifurcation atheromatous lesions. Eversion technique, similar to that used for carotid bifurcation, is safe and possible for the majority of the femoral tripod lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atheromatous
- What is being tested?
- Femoral eversion
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2014to 30 Sep 2017
- 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: Register including all patients who have been treated with the femoral eversion technique.
Who may be able to join
- Age>18 years
- Lower limb atheromatous occlusive disease.
- Stage 2 to 4 according to Rutherford's classification
Who cannot join
- Age< 18
- Previous surgery or endovascular treatment of the ipsilateral limb
- Non atheromatous disease
- Pregnancy
- Life-expectancy estimated to be less than one year
Trial locations and contacts
1 site in 1 country.
About this study
Endarteriectomy is considered as the first line treatment of femoral bifurcation atheromatous lesions. Eversion technique, similar to that used for carotid bifurcation, is safe and possible for the majority of the femoral tripod lesions. The major advantage of the eversion technique is the absence of prosthetic material to be performed. However, its use has been scarcely evaluated in the literature to date. This work aims at evaluating the long term safety and the efficacy of eversion femoral technique. Surgical technique was thoroughly described and participants were followed up for two years by serial clinical and doppler US examination.
Read the detailed description
Femoral bifurcation lesions is one of the most frequent lesion encountered in lower limb atheromatous occlusive disease. Current treatment options consists in femoral endarteriectomy or bypass. More recently, endovascular treatment of femoral tripod lesions has been reported. Inguinal area is prone to postoperative infection in up to 20% of the cases. Hence, the use of synthetic graft puts the participants at risk of dramatic consequences in case of postoperative infection. Besides, long term data are still required to validate the use of endovascular device in this very "surgical" area. The use of the eversion technique is possible in the majority of the lesions and offer the major advantage of open surgery in terms of durability, without the use of synthetic material in case of postoperative infection.
The investigators herein report the detailed technique, tips and variations of the eversion technique as well as the clinical follow up in terms of clinical benefit according to Rutherford classification and restenosis evaluated by serial doppler US.
- Conditions
- Atheromatous
- Being tested
- Femoral eversion
- Keywords
- Femoral bifurcation, Peripheral arterial disease, Vascular surgery, Eversion, Open surgery
- Medical subject headings
- Plaque, Atherosclerotic, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral eversionProcedure or surgery
The purpose of this database is to compile the data of patients followed at the René Dubos Hospital Center with symptomatic lower extremity arterial disease (AOMI) (Rutherford 2 to 5) who were operated on by the femoral tripod eversion technique.
The database will include data on the operation, possible complications, clinical course of patients and medical and surgical follow-up.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical follow-up
Observation of the clinical and life-threatening status of the participants twelve months after the operation. From a general point of view observation of clinical improvement according to Rutherford classification.
Measured: One year.
Secondary outcomes (1)
Clinical complications
Clinical follow-up and echo-Doppler was obtained at one month, six months and twelve months.
Measured: At one month, six months and twelve months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Jun 2014
- Primary completion30 Apr 2016
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtheromatousStudies 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
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel DAVAINE, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357185
- Sponsor's protocol ID
- CHRD0515
- Acronym
- Eversion
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2017
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Femoral Tripod Eversion Technique
- ClinicalTrials.gov ID
- NCT03357185
- Acronym / sponsor ID
- Eversion / CHRD0515
- Conditions
- Atheromatous
- Keywords
- Femoral bifurcation, Peripheral arterial disease, Vascular surgery, Eversion, Open surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 29 Nov 2017 (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.
Endarteriectomy is considered as the first line treatment of femoral bifurcation atheromatous lesions. Eversion technique, similar to that used for carotid bifurcation, is safe and possible for the majority of the femoral tripod lesions. The major advantage of the eversion technique is the absence of prosthetic material to be performed. However, its use has been scarcely evaluated in the literature to date. This work aims at evaluating the long term safety and the efficacy of eversion femoral technique. Surgical technique was thoroughly described and participants were followed up for two years by serial clinical and doppler US examination.
Detailed description
Femoral bifurcation lesions is one of the most frequent lesion encountered in lower limb atheromatous occlusive disease. Current treatment options consists in femoral endarteriectomy or bypass. More recently, endovascular treatment of femoral tripod lesions has been reported. Inguinal area is prone to postoperative infection in up to 20% of the cases. Hence, the use of synthetic graft puts the participants at risk of dramatic consequences in case of postoperative infection. Besides, long term data are still required to validate the use of endovascular device in this very "surgical" area. The use of the eversion technique is possible in the majority of the lesions and offer the major advantage of open surgery in terms of durability, without the use of synthetic material in case of postoperative infection.
The investigators herein report the detailed technique, tips and variations of the eversion technique as well as the clinical follow up in terms of clinical benefit according to Rutherford classification and restenosis evaluated by serial doppler US.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Register including all patients who have been treated with the femoral eversion technique.
Key inclusion criteria (3 listed)
- Age>18 years
- Lower limb atheromatous occlusive disease.
- Stage 2 to 4 according to Rutherford's classification
Key exclusion criteria (5 listed)
- Age< 18
- Previous surgery or endovascular treatment of the ipsilateral limb
- Non atheromatous disease
- Pregnancy
- Life-expectancy estimated to be less than one year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral eversionThe purpose of this database is to compile the data of patients followed at the René Dubos Hospital Center with symptomatic lower extremity arterial disease (AOMI) (Rutherford 2 to 5) who were operated on by the femoral tripod eversion technique. The database will include data on the operation, possible complications, clinical course of patients and medical and surgical follow-up. | Procedure or surgery | – |
Primary outcome
Clinical follow-up
Time frame: One year.
Observation of the clinical and life-threatening status of the participants twelve months after the operation. From a general point of view observation of clinical improvement according to Rutherford classification.
1 secondary outcome
Clinical complications
Time frame: At one month, six months and twelve months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Atheromatous
Recruiting
Carotid Plaque Characterization Using Innovative Ultrasound Techniques
Carotid Atheroma
Not yet recruitingPhase 4
A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical Atheroma
Coronary Artery Disease, Hypercholesterolemia
Not yet recruitingObservational study
The Correlation Between Sodium Urate (MSU) Deposition and Coronary Atherosclerosis in Patients With Foot Gout
Gout, Coronary Atheroma
Not yet recruitingObservational study
Cognitive Outcomes in BAD-related Stroke
Branch Atheromatous Disease, Cognitive
RecruitingObservational study
Efficacy and Safety of Intravenous Thrombolysis in Branch Atheromatous Disease
Stroke, Thrombolysis
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.
Jean-Michel DAVAINE principal investigator
Hôpital NOVO
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 Atheromatous, run by Hôpital NOVO 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical follow-up (time frame: One year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.