Carotid StenosisSIMCANCT07839390
Determination of the Best Therapeutic Strategy, Interventional With Best Medical Management (BMM) Versus BMM Alone, for Patients With Symptomatic Moderate <70% Atherosclerotic Carotid Artery Stenosis: the SIMCA Multicenter Randomized Trial
A study testing endarterectomy and stenting in people with Carotid Stenosis, run by Central Hospital, Nancy, France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- endarterectomy and stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Mar 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years
- Modified Rankin Score 0 to 3
- Atherosclerotic stenosis of the cervical internal carotid artery with
- Between 50-69% (NASCET method) confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography (DSA) OR
- 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:
- intra-plaque hemorrhage
Show all 14Show fewer
- irregular plaque surface defined as an indentation, fissure, erosion, or ulceration on the luminal surface of the plaque
- lipid-rich necrotic core (LRNC) occupying ≥50% plaque4. Symptomatic stenosis defined as clinical signs due to
- ipsilateral ischemic stroke documented on cerebral imaging OR Ipsilateral permanent or transitory retinal embolic infarction document by ophthalmologic examination OR transient ischemic attack defined as transient motor deficit and/or aphasia. AND
- obviously due to the atherosclerotic stenosis: in a concordant territory, excluding lacunar infarction, and associated cardio embolic source (atrial fibrillation excluded by ECG, and 24-hour monitoring or holter), and multiterritorial simultaneous cerebral infarctions AND
- within 14 days before planned intervention
- For whom both kinds of intervention (endarterectomy and stenting) are allowed.
- Able and willing to give consent
- Person affiliated to or beneficiary of a social security plan
Who cannot join
- Expected survival <5 years (renal clairance MDRD <30 mL/min/1.73m2, severe cardiac or respiratory insufficiency, active cancer)
- Patient unable to undergo any of both carotid revascularization (endarterectomy or stenting)
- Atrial fibrillation or medical history of atrial fibrillation
- Carotid artery stenosis due to radiotherapy
- Tandem lesion defined with the association of a severe intracranial stenosis (degree above the determining cervical internal carotid artery stenosis) or complete occlusion
- History of revascularization procedure on the determining internal carotid artery
Show all 12Show fewer
- Contra indication to dual antiplatelet therapy
- Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code:
- Pregnant, parturient or breastfeeding woman
- Minor person (non-emancipated)
- Adult person under legal protection (any form of public guardianship)
- Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Read more
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.
- Conditions
- Carotid Stenosis
- Being tested
- endarterectomy, stenting, Control group
- Keywords
- atherosclerotic Carotid Artery Stenosis (CAS)
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endarterectomyProcedure or surgery
patients treated with intervention endarterectomy plus BMM;
stentingProcedure or surgery
patients treated with intervention stenting plus BMM
Control groupOther
Patients treated with BMM alone.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | patients treated with BMM alone Receives: Other: Control group |
| Experimental group endarterectomy | Experimental | patients treated with intervention endarterectomy plus BMM Receives: Procedure: endarterectomy |
| Experimental group stenting | Experimental | patients treated with intervention stenting plus BMM Receives: Procedure: stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days after procedure and up to 5 years
Secondary outcomes (31)
Ipsilateral symptomatic cerebral or retinal infarction
occurance of Ipsilateral symptomatic cerebral infarction after randomization
Measured: 5 years follow-up
Any symptomatic ischemic stroke,
Occurance of any symptomatic ischemic stroke
Measured: 5 years follow-up
Any symptomatic stroke
Occurrence of symptomatic stroke (ischemic or hemorrhagic),
Measured: 5-year follow-up:
Myocardial infarction,
Occurence of myocardial infarction,
Measured: 5 years follow up
Vascular death,
Death atttributed to a vascular cause
Measured: 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)
Measured: 5 years follow up
Functional outcome
Modified Rankin Scale (mRS) score,
Measured: at 5 years
Health-related quality of live
Health-related quality of live assesed using EuroQol 5 Dimensions (EQ-5D-5L) questionnaire.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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 (%)
Measured: 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)
Measured: 5 years
Alcohol consumption as as Best Medical Management (BMM) compliance
Compliance with best medical management assessed from routine assessment :
- Alcohol consumption (drinks/week)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 2 years follow-up
Any symptomatic ischemic stroke at 2-years
Occurance of any symptomatic ischemic stroke
Measured: 2 years follow-up
Any symptomatic stroke at 2-years
Occurrence of symptomatic stroke (ischemic or hemorrhagic),
Measured: 2 years follow-up:
Myocardial infarction at 2-years
Occurence of myocardial infarction,
Measured: 2 years follow up
Vascular death at 2-years
Death atttributed to a vascular cause
Measured: 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)
Measured: 2 years follow up
Functional outcome at 2-years
Modified Rankin Scale (mRS) score,
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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 (%)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2034 (estimated)
- Study completion31 Mar 2035 (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 Central Hospital, Nancy, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-paralell-arms, prospective, multicenter, open randomized trial Control group: patients treated with BMM alone. Experimental group: patients treated with intervention (endarterectomy or stenting) plus BMM.
- Masking
- None (open label)
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sebastien RICHARD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839390
- Sponsor's protocol ID
- 2020PI201
- Other IDs
- 2023-A01852-43
- Acronym
- SIMCA
- Status last verified
- Sep 2026
- First submitted
- 19 May 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Best Therapeutic Strategy, Interventional With Best Medical Management (BMM) Versus BMM Alone, for Patients With Symptomatic Moderate <70% Atherosclerotic Carotid Artery Stenosis: the SIMCA Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT07839390
- Acronym / sponsor ID
- SIMCA / 2020PI201
- Conditions
- Carotid Stenosis
- Keywords
- atherosclerotic Carotid Artery Stenosis (CAS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2034 (estimated)
- Study completion
- 31 Mar 2035 (estimated)
- First posted
- 24 Sep 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3-paralell-arms, prospective, multicenter, open randomized trial Control group: patients treated with BMM alone. Experimental group: patients treated with intervention (endarterectomy or stenting) plus BMM.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Control grouppatients treated with BMM alone |
| Experimental group endarterectomy | Experimental | Procedure: endarterectomypatients treated with intervention endarterectomy plus BMM |
| Experimental group stenting | Experimental | Procedure: stentingpatients treated with intervention stenting plus BMM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 years
- Modified Rankin Score 0 to 3
- Atherosclerotic stenosis of the cervical internal carotid artery with
- For whom both kinds of intervention (endarterectomy and stenting) are allowed.
- Able and willing to give consent
Key exclusion criteria (12 listed)
- Expected survival <5 years (renal clairance MDRD <30 mL/min/1.73m2, severe cardiac or respiratory insufficiency, active cancer)
- Patient unable to undergo any of both carotid revascularization (endarterectomy or stenting)
- Atrial fibrillation or medical history of atrial fibrillation
- Carotid artery stenosis due to radiotherapy
- Tandem lesion defined with the association of a severe intracranial stenosis (degree above the determining cervical internal carotid artery stenosis) or complete occlusion
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 |
|---|---|---|
| endarterectomypatients treated with intervention endarterectomy plus BMM; | Procedure or surgery | Experimental group endarterectomy |
| stentingpatients treated with intervention stenting plus BMM | Procedure or surgery | Experimental group stenting |
| Control groupPatients treated with BMM alone. | Other | Control Group |
Primary outcome
Any stroke or death during the periprocedural period, or ipsilateral symptomatic cerebral infarction during long-term follow-up
Time frame: 30 days after procedure and up to 5 years
* 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)
31 secondary outcomes
Ipsilateral symptomatic cerebral or retinal infarction
Time frame: 5 years follow-up
Any symptomatic ischemic stroke,
Time frame: 5 years follow-up
Any symptomatic stroke
Time frame: 5-year follow-up:
Myocardial infarction,
Time frame: 5 years follow up
Vascular death,
Time frame: 5 years follow up
Cranial narve palsy
Time frame: 5 years follow up
Functional outcome
Time frame: at 5 years
Health-related quality of live
Time frame: At 5 years
Stroke or death during periprocedural phase or ipsilateral symptomatic cerebral or retinal infarction at 5-years
Time frame: periprocedural period (30 days) and 5 years follow-up
Arterial blood pressure as Best Medical Management (BMM) compliance
Time frame: 5 years
Low Density Lipoprotein (LDL) cholesterol level as Best Medical Management (BMM) compliance
Time frame: 5 years
Glycated haemoglobin level as compliance with Best Medical Management (BMM) compliance
Time frame: 5 years
Tobacco cessation as Best Medical Management (BMM) compliance
Time frame: 5 years
Alcohol consumption as as Best Medical Management (BMM) compliance
Time frame: 5 years
Daily physical activity assessment as best Medical Management (BMM) compliance
Time frame: 5 years
Any stroke or death during the periprocedural period, or ipsilateral symptomatic cerebral infarction during 2-Year follow-up
Time frame: 30 days after procedure and up to 2 years
Ipsilateral symptomatic cerebral or retinal infarction at 2-years
Time frame: 2 years follow-up
Any symptomatic ischemic stroke at 2-years
Time frame: 2 years follow-up
Any symptomatic stroke at 2-years
Time frame: 2 years follow-up:
Myocardial infarction at 2-years
Time frame: 2 years follow up
Vascular death at 2-years
Time frame: 2 years follow up
Cranial narve palsy at 2-years
Time frame: 2 years follow up
Functional outcome at 2-years
Time frame: at 2 years
Health-related quality of live at 2-years
Time frame: At 2 years
Stroke or death during periprocedural phase or ipsilateral symptomatic cerebral or retinal infarction at 2-years
Time frame: periprocedural period (30 days) and 2 years follow-up
Arterial blood pressure as Best Medical Management (BMM) compliance at 2-years
Time frame: 2 years
Low Density Lipoprotein (LDL) cholesterol level as Best Medical Management (BMM) compliance at 2-years
Time frame: 2 years
Glycated haemoglobin level as compliance with Best Medical Management (BMM) compliance at 2-years
Time frame: 2 years
Tobacco cessation as Best Medical Management (BMM) compliance at 2-years
Time frame: 2 years
Alcohol consumption as as Best Medical Management (BMM) compliance at 2-years
Time frame: 2 years
Daily physical activity assessment as best Medical Management (BMM) compliance at 2-years
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing endarterectomy and stenting in people with Carotid Stenosis, run by Central Hospital, Nancy, 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 14 inclusion and 12 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: opening soon, as of the sponsor's last update on 24 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sébastien RICHARD, Professor (03 83 85 22 56, s.richard@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any stroke or death during the periprocedural period, or ipsilateral symptomatic cerebral infarction during long-term follow-up (time frame: 30 days after procedure and up to 5 years). 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 24 Sep 2026.