NCT03464617

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

6.9 years

First QC Date

March 7, 2018

Last Update Submit

March 15, 2018

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients addressed in a vascular center for vascular ultrasound

You may qualify if:

  • Age greater than or equal to 18 years;
  • Social insured
  • Patients referred in the department for any arterial examination of the lower limbs.

You may not qualify if:

  • \- Patient unfit to understand the instructions of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU Amiens

Amiens, 80000, France

RECRUITING

CHU de Bordeaux

Bordeaux, France

RECRUITING

CHU Brest

Brest, 29000, France

RECRUITING

CHU de Caen

Caen, 14000, France

RECRUITING

CHU de Grenoble

Grenoble, 38000, France

RECRUITING

CHU de Limoges

Limoges, 87100, France

RECRUITING

CHU de Rennes

Rennes, 35033, France

RECRUITING

CHU de Saint-Etienne

Saint-Etienne, 42100, France

RECRUITING

CHU de Toulouse

Toulouse, 31555, France

RECRUITING

CH de Vichy

Vichy, 03200, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Central Study Contacts

MAHE GUILLAUME

CONTACT

02.99.28.75.29guillaume.mahe@chu-rennes.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 14, 2018

Study Start

January 15, 2016

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 19, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(10)