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CompletedNCT03357185EversionUpdated Jun 9, 2026

Prospective Evaluation of Femoral Tripod Eversion Technique

An observational study in Atheromatous, sponsored by Hôpital NOVO. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Hôpital NOVO · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
37
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Plaque, Atherosclerotic with a site in France — 5 open to participants now, 7 under way, 1 of them phase 3. Plaque, Atherosclerotic · France.

Started
2014
the only one that year
Observational
4 of 10
2 open now
Registered
3rd of 10
by date
Lead sponsor
1 of 10
Hôpital NOVO

Among the 10 studies in Plaque, Atherosclerotic with a site in France, this one is the only one that started in 2014, is one of 4 observational ones, and was the 3rd registered.

Plaque, Atherosclerotic

105 studies on the registry are indexed under Plaque, Atherosclerotic; 27 are open to participants now.

Browse Plaque, Atherosclerotic studies →

Open to participants now

5 of the 10 studies in Plaque, Atherosclerotic with a site in France are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 16 Plaque, Atherosclerotic studies recruiting now, 7 (44%) set no upper age limit and 4 (25%) stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Atheromatous

Keywords

  • Femoral bifurcation
  • Peripheral arterial disease
  • Vascular surgery
  • Eversion
  • Open surgery
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Register including all patients who have been treated with the femoral eversion technique.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age>18 years
  • Lower limb atheromatous occlusive disease.
  • Stage 2 to 4 according to Rutherford's classification

Exclusion criteria

Exclusion Criteria:

  • Age\< 18
  • Previous surgery or endovascular treatment of the ipsilateral limb
  • Non atheromatous disease
  • Pregnancy
  • Life-expectancy estimated to be less than one year
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
37 participants (actual)
Patient registry
No

Interventions

  • ProcedureFemoral eversion

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: One year.

Secondary outcomes

  1. Clinical complications

    Clinical follow-up and echo-Doppler was obtained at one month, six months and twelve months.

    Time frame: At one month, six months and twelve months.

07

Study locations

1 site
  • Hôpital NOVO
    Cergy-Pontoise, 95300, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2014 to primary completion in Apr 2016, 22 months.

Of 31 observational studies under Plaque, Atherosclerotic, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 105. This study's 22 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 24, 2017
First posted
Nov 29, 2017
StartActual
Jun 1, 2014
Primary completionActual
Apr 30, 2016
CompletionActual
Sep 30, 2017
Last update
Jun 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03357185
Lead sponsor
Hôpital NOVO
Responsible party
Sponsor
First posted
Nov 29, 2017
Start date
Jun 1, 2014
Primary completion
Apr 30, 2016
Completion
Sep 30, 2017
Last update
Jun 9, 2026

Study contacts

Jean-Michel DAVAINE
principal investigator · Hôpital NOVO

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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