An interventional study of endarterectomy and stenting in Carotid Stenosis, sponsored by Central Hospital, Nancy, France. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Treatment
Stroke is one of the leading causes of death and the main cause of long-term disability worldwide. A frequent cause is the narrowing of the carotid artery due to atherosclerosis, known as carotid artery stenosis. When stenosis is moderate (\< 70%) and has already caused symptoms, the best strategy to prevent another stroke remains uncertain. Earlier studies compared surgery or stenting with medical therapy, but these trials were conducted before modern medical treatments were available and did not consider important plaque characteristics that may increase the risk of recurrence. As a result, current clinical practice varies widely, and existing guidelines are based on low-quality evidence.
The SIMCA trial aims to address this gap by comparing two treatment strategies in patients with symptomatic moderate carotid stenosis : best medical management (BMM) alone versus BMM combined with an intervention (endarterectomy or stenting). The primary objective is To determine whether intervention (endarterectomy or stenting) plus BMM compared to BMM alone significantly reduces the incidence of ipsilateral symptomatic cerebral infarction in patients with symptomatic atherosclerotic moderate stenosis of the cervical internal carotid artery at 5 years
Hypothesis :
The arm of this study is therefore to determine the best therapeutic strategy between intervention with best medical management (BMM) versus BMM alone (main objective) and the best intervention (endarterectomy or stenting) (secondary objective) to prevent cerebral infarction in patients with symptomatic atherosclerotic moderate (\< 70%) CAS.
364 studies on the registry are indexed under Carotid Stenosis; 85 are open to participants now.
This study's planned enrollment of 1,440 is above the median of 103 across 189 interventional studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Atherosclerotic stenosis of the cervical internal carotid artery with
Stenosis \< 50% (NASCET method) confirmed by CTA or MRA or DSA with at least one of the following markers of high-risk carotid plaque features for stroke recurrence (vulnerable plaque), possibly identified by doppler ultrasound:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients treated with BMM alone
Other: Control group
patients treated with intervention endarterectomy plus BMM
Procedure: endarterectomy
patients treated with intervention stenting plus BMM
Procedure: stenting
patients treated with intervention endarterectomy plus BMM;
patients treated with intervention stenting plus BMM
Patients treated with BMM alone.
Any stroke or death during the periprocedural period, or ipsilateral symptomatic cerebral infarction during long-term follow-up
* Any stroke or death during the periprocedural period (within 30 days after procedure) * Or symptomatic cerebral or retinal infarction ipsilateral to stenosis during long-term follow-up (5 years)
Time frame: 30 days after procedure and up to 5 years
Ipsilateral symptomatic cerebral or retinal infarction
occurance of Ipsilateral symptomatic cerebral infarction after randomization
Time frame: 5 years follow-up
Any symptomatic ischemic stroke,
Occurance of any symptomatic ischemic stroke
Time frame: 5 years follow-up
Any symptomatic stroke
Occurrence of symptomatic stroke (ischemic or hemorrhagic),
Time frame: 5-year follow-up:
Myocardial infarction,
Occurence of myocardial infarction,
Time frame: 5 years follow up
Vascular death,
Death atttributed to a vascular cause
Time frame: 5 years follow up
Cranial narve palsy
Occurence of paralysis of any last cranial nerve (ranked by frequency: XII, X, VII, IX, XI, or sympathic cervical nerve with Claude Bernard Horner syndrome)
Time frame: 5 years follow up
Functional outcome
Modified Rankin Scale (mRS) score,
Time frame: at 5 years
Health-related quality of live
Health-related quality of live assesed using EuroQol 5 Dimensions (EQ-5D-5L) questionnaire.
Time frame: At 5 years
Stroke or death during periprocedural phase or ipsilateral symptomatic cerebral or retinal infarction at 5-years
Composite of any stroke or death during the periprocedural period (within 30 days after the procedure), or ipsilateral symptomatic cerebral or retinal infarction during 5 years of follow-up
Time frame: periprocedural period (30 days) and 5 years follow-up
Arterial blood pressure as Best Medical Management (BMM) compliance
compliance with best medical management assessed from • Arterial blood pressure (mmHg)
Time frame: 5 years
Low Density Lipoprotein (LDL) cholesterol level as Best Medical Management (BMM) compliance
compliance with best medical management assessed from • Low Density Lipoprotein (LDL) cholesterol level (g/L or mmol/L)
Time frame: 5 years
Glycated haemoglobin level as compliance with Best Medical Management (BMM) compliance
Compliance with best medical management assessed from routine clinical bioliological data Glycated haemoglobin level (%)
Time frame: 5 years
Tobacco cessation as Best Medical Management (BMM) compliance
Compliance with best medical management assessed from routine assessment : • Tobacco cessation or consumption (YES/NO)
Time frame: 5 years
Alcohol consumption as as Best Medical Management (BMM) compliance
Compliance with best medical management assessed from routine assessment : • Alcohol consumption (drinks/week)
Time frame: 5 years
Daily physical activity assessment as best Medical Management (BMM) compliance
compliance with best medical management assessed from routine clinical assessment : • Daily physical activity assessment (hours/week)
Time frame: 5 years
Any stroke or death during the periprocedural period, or ipsilateral symptomatic cerebral infarction during 2-Year follow-up
* Any stroke or death during the periprocedural period (within 30 days after procedure) * Or symptomatic cerebral or retinal infarction ipsilateral to stenosis during long-term follow-up (2 years)
Time frame: 30 days after procedure and up to 2 years
Ipsilateral symptomatic cerebral or retinal infarction at 2-years
occurance of Ipsilateral symptomatic cerebral infarction after randomization
Time frame: 2 years follow-up
Any symptomatic ischemic stroke at 2-years
Occurance of any symptomatic ischemic stroke
Time frame: 2 years follow-up
Any symptomatic stroke at 2-years
Occurrence of symptomatic stroke (ischemic or hemorrhagic),
Time frame: 2 years follow-up:
Myocardial infarction at 2-years
Occurence of myocardial infarction,
Time frame: 2 years follow up
Vascular death at 2-years
Death atttributed to a vascular cause
Time frame: 2 years follow up
Cranial narve palsy at 2-years
Occurence of paralysis of any last cranial nerve (ranked by frequency: XII, X, VII, IX, XI, or sympathic cervical nerve with Claude Bernard Horner syndrome)
Time frame: 2 years follow up
Functional outcome at 2-years
Modified Rankin Scale (mRS) score,
Time frame: at 2 years
Health-related quality of live at 2-years
Health-related quality of live assesed using EuroQol 5 Dimensions (EQ-5D-5L) questionnaire.
Time frame: At 2 years
Stroke or death during periprocedural phase or ipsilateral symptomatic cerebral or retinal infarction at 2-years
Composite of any stroke or death during the periprocedural period (within 30 days after the procedure), or ipsilateral symptomatic cerebral or retinal infarction during 5 years of follow-up
Time frame: periprocedural period (30 days) and 2 years follow-up
Arterial blood pressure as Best Medical Management (BMM) compliance at 2-years
compliance with best medical management assessed from • Arterial blood pressure (mmHg)
Time frame: 2 years
Low Density Lipoprotein (LDL) cholesterol level as Best Medical Management (BMM) compliance at 2-years
compliance with best medical management assessed from • Low Density Lipoprotein (LDL) cholesterol level (g/L or mmol/L)
Time frame: 2 years
Glycated haemoglobin level as compliance with Best Medical Management (BMM) compliance at 2-years
Compliance with best medical management assessed from routine clinical bioliological data Glycated haemoglobin level (%)
Time frame: 2 years
Tobacco cessation as Best Medical Management (BMM) compliance at 2-years
Compliance with best medical management assessed from routine assessment : • Tobacco cessation or consumption (YES/NO)
Time frame: 2 years
Alcohol consumption as as Best Medical Management (BMM) compliance at 2-years
Compliance with best medical management assessed from routine assessment : • Alcohol consumption (drinks/week)
Time frame: 2 years
Daily physical activity assessment as best Medical Management (BMM) compliance at 2-years
compliance with best medical management assessed from routine clinical assessment : • Daily physical activity assessment (hours/week)
Time frame: 2 years
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2034, 96 months later.
Of 50 non-industry interventional studies with no phase under Carotid Stenosis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's planned 96 months is above that.
Counting every sponsor, half of 61 studies reached it within 27 months; a quarter within 19 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France →