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Microembolisation After Carotid Revascularisation

Correlation Between Cerebral Microembolisation and Plaque Characteristics After Carotid Revascularization

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03303430
Enrollment
120
Registered
2017-10-06
Start date
2017-03-30
Completion date
2019-03-30
Last updated
2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Stenosis

Keywords

cerebral microembolisation, plaque characteristics

Brief summary

Microembolisation identified on diffusion-weighted magnetic resonance imaging (DW-MRI) is recognized as an important outcome measure for carotid revascularization procedures such as carotid stenting (CAS) or carotid endarterectomy (CEA). In fact, cerebral microembolisation occurring during revascularization procedures is associated with an increased risk of peri- and post-procedural stroke, transient ischemic attack as well as neurocognitive decline. Carotid artery stenting is a less invasive alternative to endarterectomy to treat symptomatic or asymptomatic carotid stenosis. Large randomized clinical trials showed a higher periprocedural risk of non-disabling stroke with CAS and a higher periprocedural risk of myocardial infarction, cranial nerve palsy, and access site hematoma with CEA. However little is known regarding the correlation between the morphological characteristics of the carotid plaque and the occurrence of microembolisation during the procedure and between microembolisation and midterm cognitive impairment. A few studies suggest that plaque morphology may be an important determinant for the increased risk of microembolisation. These studies however have mainly investigated microembolisation occurring during CAS and exploratory studies comparing the two procedures are still lacking. The purpose of the present study is to determine the correlation between the morphological characteristics of the carotid plaque and cerebral microembolisation either after carotid stenting or after carotid endarterectomy in patients with symptomatic or asymptomatic carotid disease.

Interventions

DIAGNOSTIC_TESTMRI

Diffusion weighted imaging 24 hours after revascularisation

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Patients presenting a symptomatic (ipsilateral ischemic stroke, TIA located in the carotid artery territory or retinal ischemia) carotid stenosis between 50% and 99% (according to NASCET and ECST criteria) * Patients presenting an asymptomatic carotid stenosis between 60% and 99% (according to NASCET and ECST criteria) Patients who accept the informed consent

Exclusion criteria

* Important neurological deficit with NIHSS \>7 (or severe aphasia) at time of inclusion * Previous known cognitive impairment * Pregnancy * Presence of contraindication based on ground of multidisciplinary team decision: * For surgery: High bifurcation Intracranial extension of the carotid stenosis Patients with tandem lesions High suspicion of severe siphon stenosis Patients with previous irradiation of the cervical region Patients with restenosis after endarterectomy * For stenting; Excessive arch vessel or carotid artery tortuosity and in particular presence tortuosity ≤90 degrees in the cervical segment Excessive aortic arch plaque burden Patients older than 70 years Unfavourable anatomic disposition as described above Co-morbidities that may preclude the use of a periprocedural dual antiplatelet regime. * For CT-scan Iodine allergy Renal insufficiency * For MRI Pacemaker Any other metallic implants Claustrophobia * For ultrasound Bad quality ultrasound (patient morphology or equipments

Design outcomes

Primary

MeasureTime frameDescription
Cerebral microembolisation24 hoursthe presence of at least 1 new hyperintense DWI lesion on the MRI realized within the 24 hours after procedure and will be correlated to the different characteristics of the carotid plaque evaluation.

Secondary

MeasureTime frameDescription
Neuropsychological assessment3 monthsNumber and locations (watershed versus territorial) of the microembolisation will be dentified on DW-MRI and will be correlated to the neuropsychological changes after the procedure

Countries

Switzerland

Contacts

Primary ContactLoraine Fisch
loraine.fisch@hcuge.ch+41795533837
Backup ContactRoman Sztajzel, MD
roman.sztajzel@hcuge.ch+41795533807

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026