Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal

NCT ID: NCT02337920

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georges Daccache, M.D

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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Caen University Hospital

Caen, Calvados, France

Site Status

Countries

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France

Other Identifiers

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TEA-NIRS

Identifier Type: -

Identifier Source: org_study_id

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