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CompletedNCT02337920TEA-NIRSUpdated Jul 21, 2017

Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal

An observational study in Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-21.

Sponsored by University Hospital, Caen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
31
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Despite effective femoral artery endarteriectomy, patients with occlusive arteritis may need complementary stenting of revascularization procedures within the 2 years after the primary surgery because of a poor blood supply in their lower limb extremity. The Near infrared spectrophotometry (NIRS) is a non-invasive monitoring of the brain or tissue oxygenation and provide information on the quality of the local oxygen supply. The aim of our observational study is to correlate the intraoperative NIRS variations at the calf and the soles and the one-year evolution of the arteritis.

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Conditions studied

  • Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy
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In context

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing unilateral femoral endarteriectomy

Inclusion criteria

  • Patients undergoing unilateral femoral endarteriectomy

Exclusion criteria

Exclusion Criteria:

  • emergency surgery, allergy to adhesive glues, skin abnormalities of the operated leg, multiple associated revascularization procedures other than endarteriectomy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
31 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Relationship between the Maximum NIRS difference before and during the femoral artery clamping and the increase of walking perimeter

    Time frame: Change - One month, six months and one year after the surgery

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Study locations

1 site
  • Caen University Hospital
    Caen, Calvados 14000, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02337920
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Jan 14, 2015
Start date
Feb 2015
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Jul 21, 2017

Study contacts

Georges Daccache, M.D
principal investigator · University Hospital, Caen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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