Status:
TERMINATED
New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis
Lead Sponsor:
Jagiellonian University
Conditions:
Carotid Artery Stenosis
Carotid Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background and purpose. Even if periprocedural cerebral microembolism associated with carotid endarterectomy or stenting usually does not manifest as clinically overt stroke, neuropsychological distur...
Detailed Description
The CARECarotid was a prospective randomised single-centre study, which was performed in the University Hospital in Kraków. It was planned to evaluate 50 patients presenting with symptomatic lesions o...
Eligibility Criteria
Inclusion
- Inclusion criteria comprised:
- patient's age ≥ 18 years;
- 60-99% stenosis of the internal carotid artery (degree of stenosis assessed by means of Doppler sonography, CT angiography or catheter angiography);
- diameter of the target internal carotid artery not more than 7 mm;
- symptomatic lesion (a history of ipsilateral stroke, transient ischaemic attack or reversible ischaemic neurological deficit);
- localisation and morphology of the lesion making possible surgical eversion endarterectomy or endovascular angioplasty with stent implantation;
- written informed consent.
- Exclusion criteria comprised:
- target lesion that has been previously stented;
- highly calcified lesions;
- very tortuous common and internal carotid arteries;
- occlusion of the contralateral carotid artery without adequate collateral circulation through the circle of Willis (revealed by means of transcranial Doppler sonography);
- anatomical contraindications for eversion endarterectomy;
- acute ipsilateral stroke;
- disabling stroke at any side;
- other severe pathologies of the brain resulting is significant loss of cerebral tissue and/or significant neurological deficits, such as extensive previous stroke or multiple lacunar infarcts;
- history of haemorrhagic transformation of ischaemic stroke;
- severe comorbidities (such as cancer or decompensated heart failure);
- allergy to aspirin, clopidogrel or ticlopidine;
- allergy to iodinated contrast media;
- pregnant women;
- women of reproductive age who do not use effective contraception;
- metallic implants (such as peacemakers and orthopaedic endoprostheses) or other known contraindications for magnetic resonance imaging;
Exclusion
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2018
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03764306
Start Date
May 1 2015
End Date
October 30 2018
Last Update
December 5 2018
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