Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2017-03-30
2019-03-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Surgery group
This patient's group will benefit from a endarteriectomy in order to treat their carotid stenosis.
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.
MRI
Diffusion weighted imaging 24 hours after revascularisation
Interventions
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MRI
Diffusion weighted imaging 24 hours after revascularisation
Eligibility Criteria
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Inclusion 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Loraine Fisch
Principal investigator
Principal Investigators
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Loraine Fisch
Role: PRINCIPAL_INVESTIGATOR
Junior consultant, neurovascular unit
Locations
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Fisch Loraine
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Loraine Fisch
Role: primary
Roman Sztajzel, MD
Role: backup
References
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Murad MH, Coto-Yglesias F, Zumaeta-Garcia M, Elamin MB, Duggirala MK, Erwin PJ, Montori VM, Gloviczki P. A systematic review and meta-analysis of the treatments of varicose veins. J Vasc Surg. 2011 May;53(5 Suppl):49S-65S. doi: 10.1016/j.jvs.2011.02.031.
Bonati LH, Fraedrich G; Carotid Stenting Trialists' Collaboration. Age modifies the relative risk of stenting versus endarterectomy for symptomatic carotid stenosis--a pooled analysis of EVA-3S, SPACE and ICSS. Eur J Vasc Endovasc Surg. 2011 Feb;41(2):153-8. doi: 10.1016/j.ejvs.2011.01.001. Epub 2011 Jan 26.
Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1.
Bonati LH, Jongen LM, Haller S, Flach HZ, Dobson J, Nederkoorn PJ, Macdonald S, Gaines PA, Waaijer A, Stierli P, Jager HR, Lyrer PA, Kappelle LJ, Wetzel SG, van der Lugt A, Mali WP, Brown MM, van der Worp HB, Engelter ST; ICSS-MRI study group. New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS). Lancet Neurol. 2010 Apr;9(4):353-62. doi: 10.1016/S1474-4422(10)70057-0. Epub 2010 Feb 25.
Gensicke H, van der Worp HB, Nederkoorn PJ, Macdonald S, Gaines PA, van der Lugt A, Mali WP, Lyrer PA, Peters N, Featherstone RL, de Borst GJ, Engelter ST, Brown MM, Bonati LH; ICSS-MRI Substudy Investigators. Ischemic brain lesions after carotid artery stenting increase future cerebrovascular risk. J Am Coll Cardiol. 2015 Feb 17;65(6):521-9. doi: 10.1016/j.jacc.2014.11.038.
Rothwell PM, Slattery J, Warlow CP. Clinical and angiographic predictors of stroke and death from carotid endarterectomy: systematic review. BMJ. 1997 Dec 13;315(7122):1571-7. doi: 10.1136/bmj.315.7122.1571.
Biasi GM, Froio A, Diethrich EB, Deleo G, Galimberti S, Mingazzini P, Nicolaides AN, Griffin M, Raithel D, Reid DB, Valsecchi MG. Carotid plaque echolucency increases the risk of stroke in carotid stenting: the Imaging in Carotid Angioplasty and Risk of Stroke (ICAROS) study. Circulation. 2004 Aug 10;110(6):756-62. doi: 10.1161/01.CIR.0000138103.91187.E3. Epub 2004 Jul 26.
Varetto G, Gibello L, Faletti R, Gattuso A, Garneri P, Castagno C, Quaglino S, Rispoli P. Contrast-enhanced ultrasound to predict the risk of microembolization during carotid artery stenting. Radiol Med. 2015 Nov;120(11):1050-5. doi: 10.1007/s11547-015-0530-4. Epub 2015 Mar 25.
Maggio P, Altamura C, Landi D, Migliore S, Lupoi D, Moffa F, Quintiliani L, Vollaro S, Palazzo P, Altavilla R, Pasqualetti P, Errante Y, Quattrocchi CC, Tibuzzi F, Passarelli F, Arpesani R, di Giambattista G, Grasso FR, Luppi G, Vernieri F. Diffusion-weighted lesions after carotid artery stenting are associated with cognitive impairment. J Neurol Sci. 2013 May 15;328(1-2):58-63. doi: 10.1016/j.jns.2013.02.019. Epub 2013 Mar 17.
Yun TJ, Sohn CH, Han MH, Yoon BW, Kang HS, Kim JE, Paeng JC, Choi SH, Kim JH, Chang KH. Effect of carotid artery stenting on cerebral blood flow: evaluation of hemodynamic changes using arterial spin labeling. Neuroradiology. 2013 Feb;55(3):271-81. doi: 10.1007/s00234-012-1104-y. Epub 2012 Oct 24.
Other Identifiers
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PLASTIS
Identifier Type: -
Identifier Source: org_study_id