Carotid StenosisRESCADINCT03631381
Retrospective Study of Carotid Surgery in Dijon
An observational study of Carotid Stenosis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The results in carotid surgery are an indicator of the functioning of an academic surgical team, making it possible to evaluate and improve practices, as much among surgeons in training as among senior surgeons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2017to Dec 2019
- 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 operated for carotid stenosis in the cardiovascular and thoracic surgery department at Dijon University Hospital since 2000
Who may be able to join
- all patients operated for carotid stenosis at Dijon University Hospital
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Eric STEINMETZ, MD, 03.80.29.33.52, eric.steinmetz@chu-dijon.fr
About this study
The results in carotid surgery are an indicator of the functioning of an academic surgical team, making it possible to evaluate and improve practices, as much among surgeons in training as among senior surgeons.
The indications have evolved with the development of symptomatic stenosis surgery, and results analysis has allowed us to improve our practices.
It would be of great use to have the statistics obtained in previous years to continue improving our practices.
- Conditions
- Carotid Stenosis
- Medical subject headings
- Carotid Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate (%)
Measured: Day 30
incidence of complications (%)
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start4 Sep 2017
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631381
- Sponsor's protocol ID
- STEINMETZ 2017
- Acronym
- RESCADI
- Status last verified
- Aug 2018
- First submitted
- 10 Aug 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Carotid Surgery in Dijon
- ClinicalTrials.gov ID
- NCT03631381
- Acronym / sponsor ID
- RESCADI / STEINMETZ 2017
- Conditions
- Carotid Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Aug 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.
The results in carotid surgery are an indicator of the functioning of an academic surgical team, making it possible to evaluate and improve practices, as much among surgeons in training as among senior surgeons.
The indications have evolved with the development of symptomatic stenosis surgery, and results analysis has allowed us to improve our practices.
It would be of great use to have the statistics obtained in previous years to continue improving our practices.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients operated for carotid stenosis in the cardiovascular and thoracic surgery department at Dijon University Hospital since 2000
Key inclusion criteria (1 listed)
- all patients operated for carotid stenosis at Dijon University Hospital
Key exclusion criteria (1 listed)
- none
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
mortality rate (%)
Time frame: Day 30
incidence of complications (%)
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Stenosis, run by Centre Hospitalier Universitaire Dijon at 1 site 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 1 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (%) (time frame: Day 30). The study lists 2 primary outcomes in all. 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 15 Aug 2018.