ClinicalTrials.gg
Status unknownNCT03847597Updated Mar 26, 2019

Histological and Imaging Assessment of the Structural Characteristics of the Femoro-popliteal Arterial Segment

An observational study in Chronic Limb Ischemia, sponsored by University Hospital, Strasbourg, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-26.

Sponsored by University Hospital, Strasbourg, France · Observational

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

The femoro-popliteal arterial segment is one of the most frequent locations for atherosclerosis. Its management is mainly endovascular (standard and coated-balloon angioplasty, stenting).

However, the structural features of the atherosclerotic disease in regards to patient's risk factors and past medical and surgical histories are not well studied. Furthermore, the histological analysis of the femoro-popliteal arterial segment is rare in the literature, and made difficult mostly because of the length of this segment.

There is a clinical need for better understanding of atherosclerotic lesions in this location, with as further goal, a better management of this disease.

02

Conditions studied

  • Chronic Limb Ischemia
03

In context

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 997 studies on the registry; 356 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Study population

Patients with chronic limb ischemia that are scheduled for transfemoral amputation

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 old
  • Men and women
  • Patient with chronic limb ischemia that is scheduled for transfemoral amputation in the University Hospital of Strasbourg
  • Patient giving his -non-opposition to the explantation and use of the femoro-popliteal arterial segment

Exclusion criteria

Exclusion criteria:

  • Refusal to give his consent
  • Impossibility to give clear information to the patient
  • Pregnant and breastfeeding women
  • Patient under administrative protection
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • ProcedureExplantation of the femoro-popliteal arterial segment from the amputed limb

    Explantation of the femoro-popliteal arterial segment from the amputed limb

06

What researchers measure

Primary outcomes

  1. Descriptive analysis of the arterial structure in micro-CT.

    study precisely the pathological structure of the femoro-popliteal arterial segment in AOMI, both in imaging and histologically.

    Time frame: 3 years

07

Study locations

1 site
  • Les Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
    • Nabil CHAKFE · Contact · nabil.chakfe@chru-strasbourg.fr · + 33 3 69 55 08 88
    • Fabien THAVEAU · Sub investigator
    • Anne LEJAY · Sub investigator
    • Yannick GEORG · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03847597
Responsible party
Sponsor
First posted
Feb 20, 2019
Start date
Apr 2019 (estimated)
Primary completion
Apr 2019 (estimated)
Completion
Feb 2022 (estimated)
Last update
Mar 26, 2019

Study contacts

Nabil CHAKFE
Contact
nabil.chakfe@chru-strasbourg.fr
+33 3 69 55 08 88
Nabil CHAKFE
principal investigator · Les Hôpitaux Universitaires de Strasbourg

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 status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion