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NCT03464617 Clinical Trial

Doppler Flow Classification of Saint-Bonnet

Peripheral Arterial Disease Clinical Trial

— Saint-Bonnet  

Official title:
Doppler Flow Classification of Saint-Bonnet : A Non Interventional Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03464617
Other study ID # 35RC18_3099_SaintBonnet
Secondary ID
Status Recruiting
Phase
First received March 7, 2018
Last updated March 15, 2018
Start date January 15, 2016
Est. completion date December 2022

Study information
Verified date March 2018
Source Rennes University Hospital
Contact MAHE GUILLAUME
Phone 02.99.28.75.29
Email guillaume.mahe@chu-rennes.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Observational Study that evaluates the interest of Doppler waveforms classification in Peripheral Artery disease

Description:

Patients who have Doppler ultrasound scanning in clinical practice currently have a systematic record of Doppler flow on arterial axes of the aorta and right and left lower limbs. The investigators will analyze a posteriori Doppler flow of patients by classifying them using the 3 classifications. The patient will have no constraints related to this study since the recordings are currently performed in clinical routine.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age greater than or equal to 18 years;

- Social insured

- Patients referred in the department for any arterial examination of the lower limbs.

Exclusion Criteria:

- Patient unfit to understand the instructions of the study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Amiens Amiens
France CHU de Bordeaux Bordeaux
France CHU Brest Brest
France CHU de Caen Caen
France CHU de Grenoble Grenoble
France CHU de Limoges Limoges
France CHU de Rennes Rennes
France CHU de Saint-Etienne Saint-Étienne
France CHU de Toulouse Toulouse
France CH de Vichy Vichy

Sponsors (1)
Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Doppler flows The difference between the number of unclassified Doppler flows using the Saint-Bonnet classification and the number of unclassified flows using the Spronk et al. This comparison will be done using the Mc Nemar test. Baseline
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