<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/NCT03764306</url>
  </required_header>
  <id_info>
    <org_study_id>137/KBL/OIL/2015</org_study_id>
    <nct_id>NCT03764306</nct_id>
  </id_info>
  <brief_title>New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis</brief_title>
  <acronym>CARECarotid</acronym>
  <official_title>New Ischemic Cerebral Lesions Revealed by the Imaging Magnetic Resonance Imaging After Endarterectomy vs. Stenting Under Proximal Protection for the Treatment of Symptomatic Carotid Stenosis: Results of a Randomised Prospective Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jagiellonian University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jagiellonian University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background and purpose. Even if periprocedural cerebral microembolism associated with carotid&#xD;
      endarterectomy or stenting usually does not manifest as clinically overt stroke,&#xD;
      neuropsychological disturbances resulting from these events represent an important clinical&#xD;
      and socioeconomic problem. Still, it remains unclear whether the use proximal protection can&#xD;
      lower the incidence of cerebral embolism associated with the treatment of carotid stenosis.&#xD;
&#xD;
      Materials and methods. This was a prospective randomised single-centre study, which was aimed&#xD;
      at comparison of surgical eversion endarterectomy with stenting under proximal protection in&#xD;
      symptomatic patients. The investigators evaluated the incidence of new ischaemic lesions&#xD;
      revealed by the diffusion-weighted magnetic resonance imaging 2-4 days after the treatment&#xD;
      and neurologic events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CARECarotid was a prospective randomised single-centre study, which was performed in the&#xD;
      University Hospital in Kraków. It was planned to evaluate 50 patients presenting with&#xD;
      symptomatic lesions of the internal carotid artery.&#xD;
&#xD;
      Patients were randomly assigned to one of the two treatment arms: surgical endarterectomy or&#xD;
      carotid angioplasty with stenting under proximal protection. All patients provided their&#xD;
      written informed consent to undergo the procedures and to participate in this trial.&#xD;
&#xD;
      In all surgical patients carotid endarterectomy will perform using the eversion technique.&#xD;
      All surgical endarterectomies will perform under cervical block anaesthesia.&#xD;
&#xD;
      Perioperatively patients in the surgical arm received aspirin; other antiplatelet or&#xD;
      anticoagulant agents were not administered during 5 days before surgery.&#xD;
&#xD;
      All procedures in carotid artery stenting will perform with proximal protection system - the&#xD;
      Mo.Ma (Medtronic, Minneapolis, MN, USA) device. The investigators will implante stents that&#xD;
      were tailored to the localisation of lesions and morphology of carotid arteries: Carotid&#xD;
      Wallstent (Boston Scientific, Natick, MA, USA, and in patients with tortuous arteries Precise&#xD;
      Pro RX (Cordis, Fremont, CA, USA) or Roadsaver (Terumo, Tokyo, Japan). Patients in the stent&#xD;
      arm will receive clopidogrel 75 mg/day and aspirin 75 mg/day. These drugs were administered&#xD;
      during 3 days before planned procedure and then 3-6 months after stent implantation. All&#xD;
      patients will have MRI DWI performed before and 2-4 days after procedures in both groups.&#xD;
      Within 6 months there will be an evaluation of the incidence of neurological events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Problem with recruitment of patients meeting the inclusion criteria.&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2015</start_date>
  <completion_date type="Actual">October 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients were randomly assigned to one of the two treatment arms: surgical endarterectomy or carotid angioplasty with stenting under proximal protection</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting and endarterectomy.</measure>
    <time_frame>2-4 days after procedure</time_frame>
    <description>Number of patients with treatment related new ipsilateral cerebral embolic lesions in brain diffusion-weighted magnetic resonance imaging within 2-4 days post carotid artery stenting and endarterectomy. Number, size and location new cerebral lesions per patients in both groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Any Stroke, TIA, MI or death</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients with occurrence of any stroke, transient ischemic attack (TIA), myocardial infarction, or death within 6 months after carotid artery stenting and endarterectomy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Carotid Artery Stenosis</condition>
  <condition>Carotid Atherosclerosis</condition>
  <condition>Stroke, Ischemic</condition>
  <arm_group>
    <arm_group_label>Carotid Artery Stenting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent with a proximal protection system Mo.Ma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endarterectomy carotid artery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will undergo carotid endarterectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Carotid Artery Stenting</intervention_name>
    <description>Carotid artery stenting was considered successful if there was no residual stenosis greater than 20%, and there was no dissection of target artery following the procedure.</description>
    <arm_group_label>Carotid Artery Stenting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endarterectomy carotid artery</intervention_name>
    <description>Surgical endarterectomy was considered successful if there was no residual stenosis after procedure, without symptoms.</description>
    <arm_group_label>Endarterectomy carotid artery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria comprised:&#xD;
&#xD;
          -  patient's age ≥ 18 years;&#xD;
&#xD;
          -  60-99% stenosis of the internal carotid artery (degree of stenosis assessed by means&#xD;
             of Doppler sonography, CT angiography or catheter angiography);&#xD;
&#xD;
          -  diameter of the target internal carotid artery not more than 7 mm;&#xD;
&#xD;
          -  symptomatic lesion (a history of ipsilateral stroke, transient ischaemic attack or&#xD;
             reversible ischaemic neurological deficit);&#xD;
&#xD;
          -  localisation and morphology of the lesion making possible surgical eversion&#xD;
             endarterectomy or endovascular angioplasty with stent implantation;&#xD;
&#xD;
          -  written informed consent.&#xD;
&#xD;
        Exclusion criteria comprised:&#xD;
&#xD;
          -  target lesion that has been previously stented;&#xD;
&#xD;
          -  highly calcified lesions;&#xD;
&#xD;
          -  very tortuous common and internal carotid arteries;&#xD;
&#xD;
          -  occlusion of the contralateral carotid artery without adequate collateral circulation&#xD;
             through the circle of Willis (revealed by means of transcranial Doppler sonography);&#xD;
&#xD;
          -  anatomical contraindications for eversion endarterectomy;&#xD;
&#xD;
          -  acute ipsilateral stroke;&#xD;
&#xD;
          -  disabling stroke at any side;&#xD;
&#xD;
          -  other severe pathologies of the brain resulting is significant loss of cerebral tissue&#xD;
             and/or significant neurological deficits, such as extensive previous stroke or&#xD;
             multiple lacunar infarcts;&#xD;
&#xD;
          -  history of haemorrhagic transformation of ischaemic stroke;&#xD;
&#xD;
          -  severe comorbidities (such as cancer or decompensated heart failure);&#xD;
&#xD;
          -  allergy to aspirin, clopidogrel or ticlopidine;&#xD;
&#xD;
          -  allergy to iodinated contrast media;&#xD;
&#xD;
          -  pregnant women;&#xD;
&#xD;
          -  women of reproductive age who do not use effective contraception;&#xD;
&#xD;
          -  metallic implants (such as peacemakers and orthopaedic endoprostheses) or other known&#xD;
             contraindications for magnetic resonance imaging;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pawel Latacz, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jagiellonian University</affiliation>
  </overall_official>
  <results_reference>
    <citation>Cremonesi A, Gieowarsingh S, Spagnolo B, Manetti R, Liso A, Furgieri A, Barattoni MC, Ghetti L, Tavazzi L, Castriota F. Safety, efficacy and long-term durability of endovascular therapy for carotid artery disease: the tailored-Carotid Artery Stenting Experience of a single high-volume centre (tailored-CASE Registry). EuroIntervention. 2009 Nov;5(5):589-98. doi: 10.4244/eijv5i5a95.</citation>
    <PMID>20142180</PMID>
  </results_reference>
  <results_reference>
    <citation>Ansel GM, Hopkins LN, Jaff MR, Rubino P, Bacharach JM, Scheinert D, Myla S, Das T, Cremonesi A; Investigators for the ARMOUR Pivotal Trial. Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial. Catheter Cardiovasc Interv. 2010 Jul 1;76(1):1-8. doi: 10.1002/ccd.22439.</citation>
    <PMID>20222019</PMID>
  </results_reference>
  <results_reference>
    <citation>Bersin RM, Stabile E, Ansel GM, Clair DG, Cremonesi A, Hopkins LN, Nikas D, Reimers B, Sievert H, Rubino P. A meta-analysis of proximal occlusion device outcomes in carotid artery stenting. Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1072-8. doi: 10.1002/ccd.24433. Epub 2012 Jul 23.</citation>
    <PMID>22454248</PMID>
  </results_reference>
  <results_reference>
    <citation>Gao MY, Sillesen HH, Lorentzen JE, Schroeder TV. Eversion carotid endarterectomy generates fewer microemboli than standard carotid endarterectomy. Eur J Vasc Endovasc Surg. 2000 Aug;20(2):153-7. doi: 10.1053/ejvs.1999.1072.</citation>
    <PMID>10942686</PMID>
  </results_reference>
  <results_reference>
    <citation>Silver FL, Mackey A, Clark WM, Brooks W, Timaran CH, Chiu D, Goldstein LB, Meschia JF, Ferguson RD, Moore WS, Howard G, Brott TG; CREST Investigators. Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2011 Mar;42(3):675-80. doi: 10.1161/STROKEAHA.110.610212. Epub 2011 Feb 9.</citation>
    <PMID>21307169</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jagiellonian University</investigator_affiliation>
    <investigator_full_name>Pawel Latacz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>carotid angioplaty</keyword>
  <keyword>MRI DWI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Stenosis</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Carotid Artery Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03764306
org study id: 137/KBL/OIL/2015
nct id: NCT03764306
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background and purpose. Even if periprocedural cerebral microembolism associated with carotid
      endarterectomy or stenting usually does not manifest as clinically overt stroke,
      neuropsychological disturbances resulting from these events represent an important clinical
      and socioeconomic problem. Still, it remains unclear whether the use proximal protection can
      lower the incidence of cerebral embolism associated with the treatment of carotid stenosis.

      Materials and methods. This was a prospective randomised single-centre study, which was aimed
      at comparison of surgical eversion endarterectomy with stenting under proximal protection in
      symptomatic patients. The investigators evaluated the incidence of new ischaemic lesions
      revealed by the diffusion-weighted magnetic resonance imaging 2-4 days after the treatment
      and neurologic events.
The CARECarotid was a prospective randomised single-centre study, which was performed in the
      University Hospital in Kraków. It was planned to evaluate 50 patients presenting with
      symptomatic lesions of the internal carotid artery.

      Patients were randomly assigned to one of the two treatment arms: surgical endarterectomy or
      carotid angioplasty with stenting under proximal protection. All patients provided their
      written informed consent to undergo the procedures and to participate in this trial.

      In all surgical patients carotid endarterectomy will perform using the eversion technique.
      All surgical endarterectomies will perform under cervical block anaesthesia.

      Perioperatively patients in the surgical arm received aspirin; other antiplatelet or
      anticoagulant agents were not administered during 5 days before surgery.

      All procedures in carotid artery stenting will perform with proximal protection system - the
      Mo.Ma (Medtronic, Minneapolis, MN, USA) device. The investigators will implante stents that
      were tailored to the localisation of lesions and morphology of carotid arteries: Carotid
      Wallstent (Boston Scientific, Natick, MA, USA, and in patients with tortuous arteries Precise
      Pro RX (Cordis, Fremont, CA, USA) or Roadsaver (Terumo, Tokyo, Japan). Patients in the stent
      arm will receive clopidogrel 75 mg/day and aspirin 75 mg/day. These drugs were administered
      during 3 days before planned procedure and then 3-6 months after stent implantation. All
      patients will have MRI DWI performed before and 2-4 days after procedures in both groups.
      Within 6 months there will be an evaluation of the incidence of neurological events.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients were randomly assigned to one of the two treatment arms: surgical endarterectomy or carotid angioplasty with stenting under proximal protection
primary purpose: Treatment
masking: Single (Investigator)
measure: The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting and endarterectomy.
time frame: 2-4 days after procedure
description: Number of patients with treatment related new ipsilateral cerebral embolic lesions in brain diffusion-weighted magnetic resonance imaging within 2-4 days post carotid artery stenting and endarterectomy. Number, size and location new cerebral lesions per patients in both groups.
measure: Any Stroke, TIA, MI or death
time frame: 6 months
description: Number of patients with occurrence of any stroke, transient ischemic attack (TIA), myocardial infarction, or death within 6 months after carotid artery stenting and endarterectomy.
arm group label: Carotid Artery Stenting
arm group type: Active Comparator
description: Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent with a proximal protection system Mo.Ma
arm group label: Endarterectomy carotid artery
arm group type: Active Comparator
description: Subjects will undergo carotid endarterectomy
intervention type: Procedure
intervention name: Carotid Artery Stenting
description: Carotid artery stenting was considered successful if there was no residual stenosis greater than 20%, and there was no dissection of target artery following the procedure.
arm group label: Carotid Artery Stenting
intervention type: Procedure
intervention name: Endarterectomy carotid artery
description: Surgical endarterectomy was considered successful if there was no residual stenosis after procedure, without symptoms.
arm group label: Endarterectomy carotid artery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pawel Latacz, PhD MD
role: Principal Investigator
affiliation: Jagiellonian University
citation: Cremonesi A, Gieowarsingh S, Spagnolo B, Manetti R, Liso A, Furgieri A, Barattoni MC, Ghetti L, Tavazzi L, Castriota F. Safety, efficacy and long-term durability of endovascular therapy for carotid artery disease: the tailored-Carotid Artery Stenting Experience of a single high-volume centre (tailored-CASE Registry). EuroIntervention. 2009 Nov;5(5):589-98. doi: 10.4244/eijv5i5a95.
PMID: 20142180
citation: Ansel GM, Hopkins LN, Jaff MR, Rubino P, Bacharach JM, Scheinert D, Myla S, Das T, Cremonesi A; Investigators for the ARMOUR Pivotal Trial. Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial. Catheter Cardiovasc Interv. 2010 Jul 1;76(1):1-8. doi: 10.1002/ccd.22439.
PMID: 20222019
citation: Bersin RM, Stabile E, Ansel GM, Clair DG, Cremonesi A, Hopkins LN, Nikas D, Reimers B, Sievert H, Rubino P. A meta-analysis of proximal occlusion device outcomes in carotid artery stenting. Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1072-8. doi: 10.1002/ccd.24433. Epub 2012 Jul 23.
PMID: 22454248
citation: Gao MY, Sillesen HH, Lorentzen JE, Schroeder TV. Eversion carotid endarterectomy generates fewer microemboli than standard carotid endarterectomy. Eur J Vasc Endovasc Surg. 2000 Aug;20(2):153-7. doi: 10.1053/ejvs.1999.1072.
PMID: 10942686
citation: Silver FL, Mackey A, Clark WM, Brooks W, Timaran CH, Chiu D, Goldstein LB, Meschia JF, Ferguson RD, Moore WS, Howard G, Brott TG; CREST Investigators. Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2011 Mar;42(3):675-80. doi: 10.1161/STROKEAHA.110.610212. Epub 2011 Feb 9.
PMID: 21307169
responsible party type: Principal Investigator
investigator affiliation: Jagiellonian University
investigator full name: Pawel Latacz
investigator title: Principal Investigator
mesh term: Carotid Stenosis
mesh term: Ischemic Stroke
mesh term: Carotid Artery Diseases
mesh term: Atherosclerosis
mesh term: Ischemia
mesh term: Constriction, Pathologic
sharing ipd: Undecided