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Trial record 97 of 112 for:    Recruiting, Not yet recruiting, Available Studies | Common carotid artery

Microembolisation After Carotid Revascularisation

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ClinicalTrials.gov Identifier: NCT03303430
Recruitment Status : Recruiting
First Posted : October 6, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Loraine Fisch, 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.


Condition or disease Intervention/treatment
Carotid Stenosis Diagnostic Test: MRI

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation Between Cerebral Microembolisation and Plaque Characteristics After Carotid Revascularization
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : March 30, 2019

Group/Cohort Intervention/treatment
Surgery group
This patient's group will benefit from a endarteriectomy in order to treat their carotid stenosis.
Diagnostic Test: MRI
Diffusion weighted imaging 24 hours after revascularisation

Stenting group
This patient's group will benefit from a stenting of their carotid in order to treat their stenosis.
Diagnostic Test: MRI
Diffusion weighted imaging 24 hours after revascularisation




Primary Outcome Measures :
  1. Cerebral microembolisation [ Time Frame: 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 :
  1. Neuropsychological assessment [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Screening of a carotid plaque is part of a routine procedure for patients admitted for stroke or TIA and includes ultrasound, CT-scan and MRI. Patients presenting a symptomatic or asymptomatic carotid stenosis are routinely discussed within a multidisciplinary meeting and the most appropriate therapeutic option is decided. For some patients, surgery and stenting are equivalent options. In that case, the patient may be a candidate for the present study
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303430


Contacts
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Contact: Loraine Fisch +41795533837 loraine.fisch@hcuge.ch
Contact: Roman Sztajzel, MD +41795533807 roman.sztajzel@hcuge.ch

Locations
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Switzerland
Fisch Loraine Recruiting
Geneva, Switzerland, 1205
Contact: Loraine Fisch    +41795533837    loraine.fisch@hcuge.ch   
Contact: Roman Sztajzel, MD    +41795533807    roman.sztajzel@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Loraine Fisch Junior consultant, neurovascular unit

Publications:

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Responsible Party: Loraine Fisch, Principal investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03303430     History of Changes
Other Study ID Numbers: PLASTIS
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Loraine Fisch, University Hospital, Geneva:
cerebral microembolisation
plaque characteristics
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases