Carotid Artery StenosisTAXINOMISISNCT03495830
Stratification of Patient With Carotid Disease
An observational study of Carotid Artery Stenosis, run by University of Belgrade at 4 sites in 4 countries.
Trial summary
Introduction: Taxinomisis trial is part of the Taxinomisis project. The concept of the Taxinomisis project is to stratify carotid artery disease relying on new modern data corresponding to contemporary patients based on information from longitudinal studies. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Carotid endarterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 29 Mar 2018to 1 Sep 2022
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with extracranial carotid stenosis greater than 50% stenosis (NASCET) in the carotid bifurcation or internal carotid artery assessed by means of ultrasound
Who may be able to join
- Extracranial carotid stenosis greater than 50% stenosis (NASCET) in the carotid bifurcation or internal carotid artery assessed by means of ultrasound;
- Ability of the patient for follow-up examinations;
- Personally signed informed consent
Who cannot join
- Previous haemorrhagic stroke,
- Non-atherosclerotic carotid stenosis (e.g. dissection, floating thrombus, fibromuscular dysplasia, postirradiation lesion)
- Presence of stenotic lesions in the proximal common carotid artery,
- Recurrent carotid stenosis after CEA or CAS,
- Carotid aneurysm
- Bilateral carotid occlusion,
Show all 13Show fewer
- Severe aortic arch calcifications and shaggy aorta
- Intracranial angioma or aneurysms,
- Severe pre-existing disability (modified Rankin scale ≥ 3);
- Contraindications for heparin, ASA and clopidogrel therapy
- Contraindication for MRI examination (metal implants, claustrophobia);
- Increased risk of thrombotic or embolic events (congenital or acquired thrombotic conditions, active untreated cancer, atrial fibrillation, severe cardiomyopathy with ejection fraction lower than 30%);
- Planned major surgery and/or life expectancy less than 3 years
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Serbia1 site
Clinic for Vascular and Endovascular Surgery, Serbian Clinical Centre
Belgrade, Serbia, 11000
About this study
Official title: Observational Multicentre Clinical Trial for Validation of Taxinomisis, New Stratification Tool for Stroke Risk in Patients With Carotid Disease
Introduction: Taxinomisis trial is part of the Taxinomisis project. The concept of the Taxinomisis project is to stratify carotid artery disease relying on new modern data corresponding to contemporary patients based on information from longitudinal studies. Taxinomisis trial will validate this tool and adjust such stratification. Initial step of the project is characterization of symptomatic and asymptomatic carotid atherosclerotic plaque lesions, identification of risk and susceptibility factors through the exploitation of longitudinal cohort data and multiomics and disintegration of carotid artery disease phenotypes into endotypes through joint modeling of multipleomics data sets and systems medicine approaches. Finally such stratification model will be validated and adjusted in the Taxinomisis clinical trial.
Read the detailed description
Aim of the trial is to validate TAXINOMISIS system for risk stratification of carotid artery stenotic disease. Primary endpoints are stroke, transitory ischemic attack or retinal symptom while secondary endpoints are MRI silent brain lesions and carotid plaque progression.
Patient with moderate to severe extra-cranial, both asymptomatic and symptomatic, carotid artery stenosis will be enrolled in the prospective observational multi-center trial in five European (Athens, Barcelona, Belgrade, Genoa, Munich and Utrecht) vascular centers. Inclusion will last from 31.3.2018 - 01.06.2019. Patients with short life expectancy, high potential of stroke from other cause or patients with complex and tandem carotid lesions will be excluded from the trial.
Included patients will be examined clinically, basic laboratory exam will be performed and part of blood specimen will be stored and assessed later. Carotid plaque will be analysed by means of duplex and MRI image while brain lesions will be detected on brain MRI.
Treatment strategy will be dependent on guidelines of good clinical practice and let independently to institutional multidisciplinary panelist board. In patients treated with carotid endarterectomy (CEA) carotid plaque will be stored and assessed for future analysis. In respect to allocated therapy patients will follow different follow up protocols.
Intervention group: Patients undergoing intervention CEA or carotid artery stenting (CAS), will be followed by clinical examination and carotid duplex on 12, 24 and 36 month. If there is coexisting contralateral carotid stenosis greater than 50% and not requiring interventional treatment (CEA or CAS), patient should cross in optimal medical therapy group.
Optimal medical therapy group: Patients not subjected to intervention (or in whom one carotid has been treated with CAS or CEA and contra-lateral stenosis is greater than 50%) will be followed with carotid duplex (at 12, 24 and 36 months) and MRI imaging of carotid tree from aortic arch up to the circle of Willis after 12 and 36 months.
Trial plans to recruit 270 patients distributed in participating centers based on individual capabilities of each center. The diagnostic performance of the new risk model, and its accuracy to discriminate high versus low risk cases for cerebrovascular complications from carotid artery disease will be evaluated using Receiver Operating Characteristic (ROC) curve analysis. The accuracy (discriminated ability) of the model will be assessed by measuring the Area under the ROC curve (AUC). An AUC 0.80 and 90% CI, for the sensitivity of prediction model of 80% with marginal error of 10%, will be targeted.
Trial will terminate after finalizing 36 months of follow up for included patients at June 2022.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Carotid endarterectomy
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid endarterectomyProcedure or surgery
Exploration of carotid bifurcation. Clamping of carotid artery and plaque removal with endarterectomy. Plaque is stored. Suture of artery with direct suture or patch.
| Study group | Role | What they receive |
|---|---|---|
| Carotid endarterectomy | Patients that underwent intervention (CEA or CAS) are followed by clinical examination and carotid duplex on 12, 24 and 36 month If there is coexisting contralateral carotid stenosis with grade greater than 50% and not requiring interventional treatment (CEA or CAS), patient should cross in optimal medical therapy group. Receives: Procedure: Carotid endarterectomy | |
| Optimal medical therapy group | Patients not subjected to intervention (or in whom one carotid has been treated with CAS or CEA and contralateral has stenosis is greater than 50%) will be followed with carotid duplex (at 12, 24 and 36 months) and MRI imaging of carotid tree from aortic arch up to the circle of Willis after 12 and 36 months. Receives: Procedure: Carotid endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined stroke, transitory ischemic attach and retinal transitory ischemic attach
rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin with CT or MRI confirmation of ischemia
Measured: 3 years
Secondary outcomes (1)
Silent brain lesions
ischemic lesions in the brain
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start29 Mar 2018
- Primary completion1 Jun 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- 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
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University of Barcelona, University of Athens, University of Genova, Utrecht University
- Responsible party
- Principal investigator, Igor Koncar, University of Belgrade
- Investigators
- Dimitris Fotiadis, PhD, Study director, University of Ionania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495830
- Sponsor's protocol ID
- STRATIFY
- Other IDs
- 755320
- Acronym
- TAXINOMISIS
- Status last verified
- Jan 2022
- First submitted
- 21 Mar 2018
- Last updated
- 6 Apr 2025
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Multicentre Clinical Trial for Validation of Taxinomisis, New Stratification Tool for Stroke Risk in Patients With Carotid Disease
- ClinicalTrials.gov ID
- NCT03495830
- Acronym / sponsor ID
- TAXINOMISIS / STRATIFY
- Conditions
- Carotid Artery Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University of Barcelona, University of Athens, University of Genova, Utrecht University
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 12 Apr 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.
Introduction: Taxinomisis trial is part of the Taxinomisis project. The concept of the Taxinomisis project is to stratify carotid artery disease relying on new modern data corresponding to contemporary patients based on information from longitudinal studies. Taxinomisis trial will validate this tool and adjust such stratification. Initial step of the project is characterization of symptomatic and asymptomatic carotid atherosclerotic plaque lesions, identification of risk and susceptibility factors through the exploitation of longitudinal cohort data and multiomics and disintegration of carotid artery disease phenotypes into endotypes through joint modeling of multipleomics data sets and systems medicine approaches. Finally such stratification model will be validated and adjusted in the Taxinomisis clinical trial.
Detailed description
Aim of the trial is to validate TAXINOMISIS system for risk stratification of carotid artery stenotic disease. Primary endpoints are stroke, transitory ischemic attack or retinal symptom while secondary endpoints are MRI silent brain lesions and carotid plaque progression.
Patient with moderate to severe extra-cranial, both asymptomatic and symptomatic, carotid artery stenosis will be enrolled in the prospective observational multi-center trial in five European (Athens, Barcelona, Belgrade, Genoa, Munich and Utrecht) vascular centers. Inclusion will last from 31.3.2018 - 01.06.2019. Patients with short life expectancy, high potential of stroke from other cause or patients with complex and tandem carotid lesions will be excluded from the trial.
Included patients will be examined clinically, basic laboratory exam will be performed and part of blood specimen will be stored and assessed later. Carotid plaque will be analysed by means of duplex and MRI image while brain lesions will be detected on brain MRI.
Treatment strategy will be dependent on guidelines of good clinical practice and let independently to institutional multidisciplinary panelist board. In patients treated with carotid endarterectomy (CEA) carotid plaque will be stored and assessed for future analysis. In respect to allocated therapy patients will follow different follow up protocols.
Intervention group: Patients undergoing intervention CEA or carotid artery stenting (CAS), will be followed by clinical examination and carotid duplex on 12, 24 and 36 month. If there is coexisting contralateral carotid stenosis greater than 50% and not requiring interventional treatment (CEA or CAS), patient should cross in optimal medical therapy group.
Optimal medical therapy group: Patients not subjected to intervention (or in whom one carotid has been treated with CAS or CEA and contra-lateral stenosis is greater than 50%) will be followed with carotid duplex (at 12, 24 and 36 months) and MRI imaging of carotid tree from aortic arch up to the circle of Willis after 12 and 36 months.
Trial plans to recruit 270 patients distributed in participating centers based on individual capabilities of each center. The diagnostic performance of the new risk model, and its accuracy to discriminate high versus low risk cases for cerebrovascular complications from carotid artery disease will be evaluated using Receiver Operating Characteristic (ROC) curve analysis. The accuracy (discriminated ability) of the model will be assessed by measuring the Area under the ROC curve (AUC). An AUC 0.80 and 90% CI, for the sensitivity of prediction model of 80% with marginal error of 10%, will be targeted.
Trial will terminate after finalizing 36 months of follow up for included patients at June 2022.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotid endarterectomy | – | Procedure: Carotid endarterectomyPatients that underwent intervention (CEA or CAS) are followed by clinical examination and carotid duplex on 12, 24 and 36 month If there is coexisting contralateral carotid stenosis with grade greater than 50% and not requiring interventional treatment (CEA or CAS), patient should cross in optimal medical therapy group. |
| Optimal medical therapy group | – | Procedure: Carotid endarterectomyPatients not subjected to intervention (or in whom one carotid has been treated with CAS or CEA and contralateral has stenosis is greater than 50%) will be followed with carotid duplex (at 12, 24 and 36 months) and MRI imaging of carotid tree from aortic arch up to the circle of Willis after 12 and 36 months. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with extracranial carotid stenosis greater than 50% stenosis (NASCET) in the carotid bifurcation or internal carotid artery assessed by means of ultrasound
Key inclusion criteria (3 listed)
- Extracranial carotid stenosis greater than 50% stenosis (NASCET) in the carotid bifurcation or internal carotid artery assessed by means of ultrasound;
- Ability of the patient for follow-up examinations;
- Personally signed informed consent
Key exclusion criteria (13 listed)
- Previous haemorrhagic stroke,
- Non-atherosclerotic carotid stenosis (e.g. dissection, floating thrombus, fibromuscular dysplasia, postirradiation lesion)
- Presence of stenotic lesions in the proximal common carotid artery,
- Recurrent carotid stenosis after CEA or CAS,
- Carotid aneurysm
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 |
|---|---|---|
| Carotid endarterectomyExploration of carotid bifurcation. Clamping of carotid artery and plaque removal with endarterectomy. Plaque is stored. Suture of artery with direct suture or patch. | Procedure or surgery | Carotid endarterectomy, Optimal medical therapy group |
Primary outcome
Combined stroke, transitory ischemic attach and retinal transitory ischemic attach
Time frame: 3 years
rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin with CT or MRI confirmation of ischemia
1 secondary outcome
Silent brain lesions
Time frame: 3 years
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 6 Apr 2025.
- 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. This study is not recruiting at the moment.
Dimitris Fotiadis, PhD study director
University of Ionania
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis, run by University of Belgrade at 4 sites in 4 countries.
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 13 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 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Netherlands, Serbia, Spain. 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?
Combined stroke, transitory ischemic attach and retinal transitory ischemic attach (time frame: 3 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 6 Apr 2025.