Lower Limb Vascular Surgery - Femoral Artery EndarteriectomyTEA-NIRSNCT02337920
Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal
An observational study of Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy, run by University Hospital, Caen at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Feb 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing unilateral femoral endarteriectomy
Who may be able to join
- Patients undergoing unilateral femoral endarteriectomy
Who cannot join
- emergency surgery, allergy to adhesive glues, skin abnormalities of the operated leg, multiple associated revascularization procedures other than endarteriectomy
Trial locations and contacts
1 site in 1 country.
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between the Maximum NIRS difference before and during the femoral artery clamping and the increase of walking perimeter
Measured: Change - One month, six months and one year after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Vascular Surgery - Femoral Artery EndarteriectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges Daccache, M.D, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337920
- Sponsor's protocol ID
- TEA-NIRS
- Acronym
- TEA-NIRS
- Status last verified
- Jul 2015
- First submitted
- 27 Nov 2014
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal
- ClinicalTrials.gov ID
- NCT02337920
- Acronym / sponsor ID
- TEA-NIRS / TEA-NIRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Jan 2015 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing unilateral femoral endarteriectomy
Key inclusion criteria (1 listed)
- Patients undergoing unilateral femoral endarteriectomy
Key exclusion criteria (1 listed)
- emergency surgery, allergy to adhesive glues, skin abnormalities of the operated leg, multiple associated revascularization procedures other than endarteriectomy
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
Relationship between the Maximum NIRS difference before and during the femoral artery clamping and the increase of walking perimeter
Time frame: Change - One month, six months and one year after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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.
Georges Daccache, M.D principal investigator
University Hospital, Caen
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 Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy, run by University Hospital, Caen 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: finished, as of the sponsor's last update on 21 Jul 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between the Maximum NIRS difference before and during the femoral artery clamping and the increase of walking perimeter (time frame: Change - One month, six months and one year after the surgery). 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 21 Jul 2017.