Microembolisation After Carotid Revascularisation

• Conditions: Carotid Stenosis
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT03303430
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-30
• Status Verified: 2017-10
• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-05
• Last Update Submitted: 2017-10-05
• Study First Posted: 2017-10-06
• Last Update Posted: 2017-10-06
• Primary Completion: 2019-03-30
• Study Completion: 2019-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery group	MRI	This patient's group will benefit from a endarteriectomy in order to treat their carotid stenosis.
Stenting group	MRI	This patient's group will benefit from a stenting of their carotid in order to treat their stenosis.

Primary Outcome Measures

Name	Time	Method
Cerebral microembolisation	24 hours	the 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 Outcome Measures

Name	Time	Method
Neuropsychological assessment	3 months	Number 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

Trial Locations

Locations (1)

Fisch Loraine; 🇨🇭 Geneva, Switzerland