<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03303430</url>
  </required_header>
  <id_info>
    <org_study_id>PLASTIS</org_study_id>
    <nct_id>NCT03303430</nct_id>
  </id_info>
  <brief_title>Microembolisation After Carotid Revascularisation</brief_title>
  <official_title>Correlation Between Cerebral Microembolisation and Plaque Characteristics After Carotid Revascularization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Microembolisation identified on diffusion-weighted magnetic resonance imaging (DW-MRI) is&#xD;
      recognized as an important outcome measure for carotid revascularization procedures such as&#xD;
      carotid stenting (CAS) or carotid endarterectomy (CEA). In fact, cerebral microembolisation&#xD;
      occurring during revascularization procedures is associated with an increased risk of peri-&#xD;
      and post-procedural stroke, transient ischemic attack as well as neurocognitive decline.&#xD;
      Carotid artery stenting is a less invasive alternative to endarterectomy to treat symptomatic&#xD;
      or asymptomatic carotid stenosis. Large randomized clinical trials showed a higher&#xD;
      periprocedural risk of non-disabling stroke with CAS and a higher periprocedural risk of&#xD;
      myocardial infarction, cranial nerve palsy, and access site hematoma with CEA.&#xD;
&#xD;
      However little is known regarding the correlation between the morphological characteristics&#xD;
      of the carotid plaque and the occurrence of microembolisation during the procedure and&#xD;
      between microembolisation and midterm cognitive impairment. A few studies suggest that plaque&#xD;
      morphology may be an important determinant for the increased risk of microembolisation. These&#xD;
      studies however have mainly investigated microembolisation occurring during CAS and&#xD;
      exploratory studies comparing the two procedures are still lacking.&#xD;
&#xD;
      The purpose of the present study is to determine the correlation between the morphological&#xD;
      characteristics of the carotid plaque and cerebral microembolisation either after carotid&#xD;
      stenting or after carotid endarterectomy in patients with symptomatic or asymptomatic carotid&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 30, 2017</start_date>
  <completion_date type="Anticipated">March 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cerebral microembolisation</measure>
    <time_frame>24 hours</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological assessment</measure>
    <time_frame>3 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Carotid Stenosis</condition>
  <arm_group>
    <arm_group_label>Surgery group</arm_group_label>
    <description>This patient's group will benefit from a endarteriectomy in order to treat their carotid stenosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stenting group</arm_group_label>
    <description>This patient's group will benefit from a stenting of their carotid in order to treat their stenosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Diffusion weighted imaging 24 hours after revascularisation</description>
    <arm_group_label>Stenting group</arm_group_label>
    <arm_group_label>Surgery group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Screening of a carotid plaque is part of a routine procedure for patients admitted for&#xD;
        stroke or TIA and includes ultrasound, CT-scan and MRI. Patients presenting a symptomatic&#xD;
        or asymptomatic carotid stenosis are routinely discussed within a multidisciplinary meeting&#xD;
        and the most appropriate therapeutic option is decided. For some patients, surgery and&#xD;
        stenting are equivalent options. In that case, the patient may be a candidate for the&#xD;
        present study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting a symptomatic (ipsilateral ischemic stroke, TIA located in the&#xD;
             carotid artery territory or retinal ischemia) carotid stenosis between 50% and 99%&#xD;
             (according to NASCET and ECST criteria)&#xD;
&#xD;
          -  Patients presenting an asymptomatic carotid stenosis between 60% and 99% (according to&#xD;
             NASCET and ECST criteria) Patients who accept the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Important neurological deficit with NIHSS &gt;7 (or severe aphasia) at time of inclusion&#xD;
&#xD;
          -  Previous known cognitive impairment&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Presence of contraindication based on ground of multidisciplinary team decision:&#xD;
&#xD;
               -  For surgery:&#xD;
&#xD;
        High bifurcation Intracranial extension of the carotid stenosis Patients with tandem&#xD;
        lesions High suspicion of severe siphon stenosis Patients with previous irradiation of the&#xD;
        cervical region Patients with restenosis after endarterectomy&#xD;
&#xD;
          -  For stenting; Excessive arch vessel or carotid artery tortuosity and in particular&#xD;
             presence tortuosity ≤90 degrees in the cervical segment Excessive aortic arch plaque&#xD;
             burden Patients older than 70 years Unfavourable anatomic disposition as described&#xD;
             above Co-morbidities that may preclude the use of a periprocedural dual antiplatelet&#xD;
             regime.&#xD;
&#xD;
          -  For CT-scan Iodine allergy Renal insufficiency&#xD;
&#xD;
          -  For MRI Pacemaker Any other metallic implants Claustrophobia&#xD;
&#xD;
          -  For ultrasound Bad quality ultrasound (patient morphology or equipments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Loraine Fisch</last_name>
    <role>Principal Investigator</role>
    <affiliation>Junior consultant, neurovascular unit</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Loraine Fisch</last_name>
    <phone>+41795533837</phone>
    <email>loraine.fisch@hcuge.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Roman Sztajzel, MD</last_name>
    <phone>+41795533807</phone>
    <email>roman.sztajzel@hcuge.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fisch Loraine</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Loraine Fisch</last_name>
      <phone>+41795533837</phone>
      <email>loraine.fisch@hcuge.ch</email>
    </contact>
    <contact_backup>
      <last_name>Roman Sztajzel, MD</last_name>
      <phone>+41795533807</phone>
      <email>roman.sztajzel@hcuge.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>21536173</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21269847</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: Stroke. 2015 Feb;46(2):e54.</citation>
    <PMID>24788967</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: Lancet Neurol. 2010 Apr;9(4):345. Waajier, Annet [corrected to Waaijer, Annet].</citation>
    <PMID>20189458</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25677309</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9437274</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15277320</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25805183</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23510565</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23093072</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Loraine Fisch</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>cerebral microembolisation</keyword>
  <keyword>plaque characteristics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03303430
org study id: PLASTIS
nct id: NCT03303430
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: No
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.
observational model: Case-Only
time perspective: Prospective
measure: Cerebral microembolisation
time frame: 24 hours
description: 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.
measure: Neuropsychological assessment
time frame: 3 months
description: 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
arm group label: Surgery group
description: This patient's group will benefit from a endarteriectomy in order to treat their carotid stenosis.
arm group label: Stenting group
description: This patient's group will benefit from a stenting of their carotid in order to treat their stenosis.
intervention type: Diagnostic Test
intervention name: MRI
description: Diffusion weighted imaging 24 hours after revascularisation
arm group label: Stenting group
arm group label: Surgery group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Loraine Fisch
role: Principal Investigator
affiliation: Junior consultant, neurovascular unit
last name: Loraine Fisch
phone: +41795533837
email: loraine.fisch@hcuge.ch
last name: Roman Sztajzel, MD
phone: +41795533807
email: roman.sztajzel@hcuge.ch
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
citation: 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.
PMID: 21536173
citation: 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.
PMID: 21269847
citation: 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. Erratum In: Stroke. 2015 Feb;46(2):e54.
PMID: 24788967
citation: 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. Erratum In: Lancet Neurol. 2010 Apr;9(4):345. Waajier, Annet [corrected to Waaijer, Annet].
PMID: 20189458
citation: 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.
PMID: 25677309
citation: 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.
PMID: 9437274
citation: 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.
PMID: 15277320
citation: 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.
PMID: 25805183
citation: 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.
PMID: 23510565
citation: 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.
PMID: 23093072
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Loraine Fisch
investigator title: Principal investigator
mesh term: Carotid Stenosis
sharing ipd: No