Peripheral Arterial DiseaseSaint-BonnetNCT03464617
Doppler Flow Classification of Saint-Bonnet
An observational study of Peripheral Arterial Disease, run by Rennes University Hospital at 10 sites in France.
Trial summary
Observational Study that evaluates the interest of Doppler waveforms classification in Peripheral Artery disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 1,000 participants
- Where
- 10 sitesFrance
- Study dates
- 15 Jan 2016to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients addressed in a vascular center for vascular ultrasound
Who may be able to join
- Age greater than or equal to 18 years;
- Social insured
- Patients referred in the department for any arterial examination of the lower limbs.
Who cannot join
- Patient unfit to understand the instructions of the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
CHU Amiens
Amiens, 80000
SEVESTRE
- Recruiting
CHU de Bordeaux
Bordeaux
CONSTANS
- Recruiting
CHU Brest
Brest, 29000
LUC BRESSOLLETTE, MD PhD, luc.bressollette@chu-brest.fr
- Recruiting
CHU de Caen
Caen, 14000
LANEELLE
- Recruiting
CHU de Grenoble
Grenoble, 38000
PERNOD
- Recruiting
CHU de Limoges
Limoges, 87100
LACROIX
- Recruiting
CHU de Rennes
Rennes, 35033
MAHE GUILLAUME, 02.99.28.75.29, guillaume.mahe@chu-rennes.fr
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42100
HELLO CLAIRE
- Recruiting
CHU de Toulouse
Toulouse, 31555
BURA-RIVIERE
- Recruiting
CH de Vichy
Vichy, 03200
ABBADIE FABRICE
About this study
Official title: Doppler Flow Classification of Saint-Bonnet : A Non Interventional Clinical Trial
Observational Study that evaluates the interest of Doppler waveforms classification in Peripheral Artery disease
Read the detailed 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.
- Conditions
- Peripheral Arterial Disease
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start15 Jan 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464617
- Sponsor's protocol ID
- 35RC18_3099_SaintBonnet
- Acronym
- Saint-Bonnet
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler Flow Classification of Saint-Bonnet : A Non Interventional Clinical Trial
- ClinicalTrials.gov ID
- NCT03464617
- Acronym / sponsor ID
- Saint-Bonnet / 35RC18_3099_SaintBonnet
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational Study that evaluates the interest of Doppler waveforms classification in Peripheral Artery disease
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients addressed in a vascular center for vascular ultrasound
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years;
- Social insured
- Patients referred in the department for any arterial examination of the lower limbs.
Key exclusion criteria (1 listed)
- Patient unfit to understand the instructions of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Doppler flows
Time frame: Baseline
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Rennes University Hospital at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MAHE GUILLAUME (02.99.28.75.29, guillaume.mahe@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doppler flows (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.