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Clinical Trials/NCT02337920
NCT02337920
Completed
Not Applicable

Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal

University Hospital, Caen1 site in 1 country31 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy
Sponsor
University Hospital, Caen
Enrollment
31
Locations
1
Primary Endpoint
Relationship between the Maximum NIRS difference before and during the femoral artery clamping and the increase of walking perimeter
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
February 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing unilateral femoral endarteriectomy

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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