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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03495830 |
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Date of registration:
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21/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Stratification of Patient With Carotid Disease
TAXINOMISIS |
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Scientific title:
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Observational Multicentre Clinical Trial for Validation of Taxinomisis, New Stratification Tool for Stroke Risk in Patients With Carotid Disease |
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Date of first enrolment:
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March 29, 2018 |
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Target sample size:
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270 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03495830 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Germany
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Netherlands
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Serbia
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Spain
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Contacts
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Name:
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Themis Exarchos, PhD |
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Address:
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Telephone:
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00306947709387 |
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Email:
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themis.exarchos@gmail.com |
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Affiliation:
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Name:
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Dimitris Fotiadis, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Ionania |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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,
- 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
Age minimum:
40 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Carotid Artery Stenosis
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Intervention(s)
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Procedure: Carotid endarterectomy
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Primary Outcome(s)
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Combined stroke, transitory ischemic attach and retinal transitory ischemic attach
[Time Frame: 3 years]
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Secondary Outcome(s)
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Silent brain lesions
[Time Frame: 3 years]
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Secondary ID(s)
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755320
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STRATIFY
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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