HyperplasiaTRECNCT06272305
TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis
An observational study of Hyperplasia, run by University Hospital, Angers.
Trial summary
Restenosis due to myo-intimal hyperplasia remains a concern after carotid endarterectomy. It occurs in around 6% of cases. Several risk factors for restenosis have already been identified, such as smoking, hypertension, female gender, diabetes, dyslipidemia and small carotid diameter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperplasia
- What is being tested?
- This research does not require any specific investigation and does not imply any modification of treatment.
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Jun 2024
- 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: Any patient who is having carotid endarterectomy by eversion
Who may be able to join
- Any patient who is having carotid endarterectomy by eversion according to HAS + ESVS recommendations :
- Stenosis > 70% on dopplerin the absence of neurological symptoms attributable to the carotid territory affected by the stenotic artery.
- Stenosis > 50% with neurological symptoms attributable to the carotid territory affected by the stenotic artery.
Who cannot join
- Any carotid revascularization technique other than eversion (carotid endarterectomy with patch, carotid resection-anastomosis or bypass).
- Cardiac surgery combined with carotid surgery
- Minor patients
- Endovascular carotid surgery
- Opposition to use patient's data
Trial locations and contacts
No sites are listed yet.
About this study
Restenosis due to myo-intimal hyperplasia remains a concern after carotid endarterectomy. It occurs in around 6% of cases. Several risk factors for restenosis have already been identified, such as smoking, hypertension, female gender, diabetes, dyslipidemia and small carotid diameter. The main objective of this prospective multicenter study was to determine whether the technical characteristics of the eversion technique have an influence on the rate of restenosis at 1 year.
Between September 2021 and November 2022, we followed all patients undergoing carotid endarterectomy by eversion in 8 French hospitals. Demographic data, operative indications and technical characteristics of the endarterectomies performed were collected. These were defined by the circumferential nature of the carotid bulb according to 3 types (TREC A, B or C), and the length and depth of the endarterectomy according to anatomopathological reports. Post-operative complications were collected as much as doppler ultrasonography at three months and 1 year to quantify restenosis.
Read the detailed description
Before the surgery, the following data is collected :
- General data: Sex, age, weight, height
- History and cardiovascular risk factors: diabetes, high blood pressure, dyslipidemia, smoking, chronic renal failure, etc.
- Current treatments taken by the patient
- The degree of initial stenosis of the carotid artery of interest on duplex ultrasound as well as on CT angiography
- The context of endarterectomy if it occurs following a stroke or preventively.
Data to be recovered post-operatively from carotid surgery :
- The operative report specifying the circumferential nature of the carotid endarterectomy on the common carotid-external carotid axis. 3 possible categories: no endarterectomy, non-circumferential partial endarterectomy, circumferential endarterectomy.
- Post-operative doppler (< 1 month) assessing the presence of residual stenosis.
- The patient's operative consequences with the occurrence of intercurrent cardiological events (cardiological, biological or electrocardiographic), neurological (central or peripheral), post-operative complications such as cervical hematoma.
Visit between month 1 and month 3 :
- The anatomopathological report specifying: Length of the endarterectomy part in millimeters and the depth of the endarterectomy according to the location of the separation plane at the level of the artery wall (deep or superficial intimal plane).
- Doppler assessing the presence of carotid restenosis
- The occurrence of central neurological events that may be related to the endarterectomized carotid artery
Visit at one year :
- Doppler assessing the presence of carotid restenosis
- The occurrence of central neurological events that may be related to the endarterectomized carotid artery
- Conditions
- Hyperplasia
- Being tested
- This research does not require any specific investigation and does not imply any modification of treatment.
- Medical subject headings
- Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This research does not require any specific investigation and does not imply any modification of treatment.Procedure or surgery
Collection of data from the medical record for patients with a non specific carotid endarterectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of restenosis
The main objective is to evaluate the rate of restenosis at doppler(defined as restenosis ≥50%(NASCET/ECST)) occurring at one year, according to the technical characteristics of the eversion. They are defined according to three distinct criteria: the circumferential nature of the endarterectomy at the level of the carotid bifurcation, the length of the endarterectomy and its depth in the plane of the intima.
Measured: one year
Secondary outcomes (3)
Morbidity and mortality rate
Cumulative morbidity and mortality rate at 30 days defined by:
- All-cause mortality within 30 days post-op
- Major neurological event defined as the occurrence of a stroke (focal signs lasting more than 24 hours, confirmed by brain imaging)
Measured: 30 days
Major cardiological event
Major cardiological event defined by troponin elevation with chest pain (or equivalent symptom) and/or ECG changes in favor of myocardial ischemia
Measured: one year
Minor neurological events
Minor neurological events: peripheral neurological and/or cranial nerve damage (tongue deviation, dysphonia, swallowing disorder).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperplasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nicolas RIFFET-VIDAL, University Hospital, Angers
- Investigators
- Gautier HAUPERT, Dr, Principal investigator, university hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272305
- Sponsor's protocol ID
- 49RC21_0301
- Acronym
- TREC
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 22 Feb 2024
- 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 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis
- ClinicalTrials.gov ID
- NCT06272305
- Acronym / sponsor ID
- TREC / 49RC21_0301
- Conditions
- Hyperplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 22 Feb 2024 (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.
Restenosis due to myo-intimal hyperplasia remains a concern after carotid endarterectomy. It occurs in around 6% of cases. Several risk factors for restenosis have already been identified, such as smoking, hypertension, female gender, diabetes, dyslipidemia and small carotid diameter. The main objective of this prospective multicenter study was to determine whether the technical characteristics of the eversion technique have an influence on the rate of restenosis at 1 year.
Between September 2021 and November 2022, we followed all patients undergoing carotid endarterectomy by eversion in 8 French hospitals. Demographic data, operative indications and technical characteristics of the endarterectomies performed were collected. These were defined by the circumferential nature of the carotid bulb according to 3 types (TREC A, B or C), and the length and depth of the endarterectomy according to anatomopathological reports. Post-operative complications were collected as much as doppler ultrasonography at three months and 1 year to quantify restenosis.
Detailed description
Before the surgery, the following data is collected :
- General data: Sex, age, weight, height
- History and cardiovascular risk factors: diabetes, high blood pressure, dyslipidemia, smoking, chronic renal failure, etc.
- Current treatments taken by the patient
- The degree of initial stenosis of the carotid artery of interest on duplex ultrasound as well as on CT angiography
- The context of endarterectomy if it occurs following a stroke or preventively.
Data to be recovered post-operatively from carotid surgery :
- The operative report specifying the circumferential nature of the carotid endarterectomy on the common carotid-external carotid axis. 3 possible categories: no endarterectomy, non-circumferential partial endarterectomy, circumferential endarterectomy.
- Post-operative doppler (< 1 month) assessing the presence of residual stenosis.
- The patient's operative consequences with the occurrence of intercurrent cardiological events (cardiological, biological or electrocardiographic), neurological (central or peripheral), post-operative complications such as cervical hematoma.
Visit between month 1 and month 3 :
- The anatomopathological report specifying: Length of the endarterectomy part in millimeters and the depth of the endarterectomy according to the location of the separation plane at the level of the artery wall (deep or superficial intimal plane).
- Doppler assessing the presence of carotid restenosis
- The occurrence of central neurological events that may be related to the endarterectomized carotid artery
Visit at one year :
- Doppler assessing the presence of carotid restenosis
- The occurrence of central neurological events that may be related to the endarterectomized carotid artery
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
- Any patient who is having carotid endarterectomy by eversion
Key inclusion criteria (3 listed)
- Any patient who is having carotid endarterectomy by eversion according to HAS + ESVS recommendations :
- Stenosis > 70% on dopplerin the absence of neurological symptoms attributable to the carotid territory affected by the stenotic artery.
- Stenosis > 50% with neurological symptoms attributable to the carotid territory affected by the stenotic artery.
Key exclusion criteria (5 listed)
- Any carotid revascularization technique other than eversion (carotid endarterectomy with patch, carotid resection-anastomosis or bypass).
- Cardiac surgery combined with carotid surgery
- Minor patients
- Endovascular carotid surgery
- Opposition to use patient's data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This research does not require any specific investigation and does not imply any modification of treatment.Collection of data from the medical record for patients with a non specific carotid endarterectomy | Procedure or surgery | – |
Primary outcome
Rate of restenosis
Time frame: one year
The main objective is to evaluate the rate of restenosis at doppler(defined as restenosis ≥50%(NASCET/ECST)) occurring at one year, according to the technical characteristics of the eversion. They are defined according to three distinct criteria: the circumferential nature of the endarterectomy at the level of the carotid bifurcation, the length of the endarterectomy and its depth in the plane of the intima.
3 secondary outcomes
Morbidity and mortality rate
Time frame: 30 days
Major cardiological event
Time frame: one year
Minor neurological events
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Hyperplasia
Active, not recruitingPhase 1
RT-310 Dose Escalation BPH Study
BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
Active, not recruitingPhase 1/2
RT-310 Safety and Feasibility BPH Study
BPH (Benign Prostatic Hyperplasia)
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
Lymphoproliferative Disorder, HHV-8
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.
Gautier HAUPERT, Dr principal investigator
university hospital of Angers
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperplasia, run by University Hospital, Angers.
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 5 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 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Gautier HAUPERT, Dr (02 41 35 38 38, gautier.haupert@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of restenosis (time frame: one year). 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 22 Feb 2024.