<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/NCT03266289</url>
  </required_header>
  <id_info>
    <org_study_id>17100301</org_study_id>
    <nct_id>NCT03266289</nct_id>
  </id_info>
  <brief_title>Evaluation of Short Term Outcome of Different Bifurcation Stenting Techniques at Assuit University Cath. Lab</brief_title>
  <official_title>Evaluation of Short Term Outcome of Different Bifurcation Stenting Techniques at Assuit University Cath. Lab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MA Abdelreheem</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary aim: evaluation of the short term outcome of different techniques used in&#xD;
      bifurcational coronary arteries intervention regarding major adverse cardiac event (MACE):&#xD;
      cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis&#xD;
      and occurrence of Unstable angina (UA) with ECG changes and echo findings in the same target&#xD;
      vessel in Assiut university Cath. lab.&#xD;
&#xD;
      Secondary aim: calculation of the percentage of bifurcational coronary arteries intervention&#xD;
      in Assiut University Cath.lab&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      IntroductionCoronary artery bifurcation lesions comprise one of the more complex lesion&#xD;
      subsetsroutinely faced in interventional cardiology, accounting for up to 20% of all&#xD;
      coronarydiseases treated by percutaneous coronary intervention (PCI) The technical&#xD;
      difficulties inherent in the treatment of bifurcation lesions, associatedwith their lower&#xD;
      success and higher complication rates compared with non-bifurcationlesions, have always been&#xD;
      the object of intense research activity, with publication ofcontemporary studies in the past&#xD;
      few years contributing significantly to the decisionmaking process.Bifurcation lesions are&#xD;
      challenging to categorize, since they are variable not only intheir anatomy (location of&#xD;
      plaque, plaque burden, angle between branches, site ofbifurcation, and size of branches), but&#xD;
      also in the dynamic anatomic changes duringtreatment caused by dissections and carina shift.&#xD;
      Despite these challenges complicatingclassification of bifurcation lesions, many definitions&#xD;
      have been proposed in an effort tounify this common clinical situation. A coronary&#xD;
      bifurcation lesion is defined as (coronary artery narrowing occurringadjacent to, and/or&#xD;
      involving, the origin of a significant side branch). A significant sidebranch (SB) is a&#xD;
      branch that, if lost, can impact the prognosis of the patient. General different&#xD;
      classifications of coronary bifurcation lesions have been proposed, dueto the variety of&#xD;
      possible bifurcation lesions, with different technical implications,treatment options, and&#xD;
      prognosis. The most used, for its simplicity and reproducibility,is the Medina&#xD;
      classification. This classification is based on the presence or absence ofnarrowing &gt;50% on&#xD;
      each of the three components of the bifurcation: the main branchproximal (MBP), the main&#xD;
      branch distal, and the SB. A value of 0 or 1 is assigned toeach of the three segments in the&#xD;
      following order: MBP, main branch distal, and SB. Forexample, a bifurcation lesion involving&#xD;
      the MBP and the SB would be defined as 1, 0,1. Seven morphologies are therefore possible.&#xD;
      Despite being the most usedclassification, the Medina has several limitations, since it does&#xD;
      not consider the plaqueburden, branch diameter, lesion length, bifurcation angles, the&#xD;
      presence of ostialdisease, or calcification.&#xD;
&#xD;
      The goal of percutaneous coronary intervention in bifurcation lesions is tomaximize flow in&#xD;
      the main branch (MB), maintain flow in the SB, prevent its occlusion,and maximize long-term&#xD;
      patency. Data about bifurcational lesions percentage and short term outcome of&#xD;
      differenttechniques used in intervention in our cath lab is still unknown.Aim of the study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary aim: evaluation of the short term outcome of different techniques used in bifurcational coronary arteries intervention</measure>
    <time_frame>1 year</time_frame>
    <description>Primary aim: evaluation of the short term outcome of different techniques used in bifurcational coronary arteries intervention regarding major adverse cardiac event (MACE): cardiac death, myocardial infarction, target vessel revascularization, or stent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary aim: calculation of the percentage of bifurcational coronary arteries intervention in Assiut University Cath.lab</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>STEMI - ST Elevation Myocardial Infarction</condition>
  <condition>Unstable Angina</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study will include patients diagnosed as bifurcational coronary arteries Iesion&#xD;
        underwent intervention&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with true bifurcational coronary arteries lesion defined as (lesions in&#xD;
             which there is more than 50% diameter stenosis in both the parent vessel and the&#xD;
             ostium of the side branch arising from the lesion, and both are more than 2.0 mm in&#xD;
             diameter by visual estimation) (13) undergoing intervention either urgent or elective&#xD;
             in Assiut university Cath. lab during period from September 2017 to September 2018&#xD;
             will be included in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Contraindications to PCI of bifurcation lesions would be any patient unwilling to&#xD;
             undergo PCI, coronary anatomy that is not amenable to PCI (e.g., small caliber with&#xD;
             diffuse disease), intermediate lesions in the absence of symptoms, and/or subjective&#xD;
             evidence of ischemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amr A. Youssef, Prof doctor</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed A. Abdelhafez, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed A. Abdelreheem, Residant</last_name>
    <phone>01119535430</phone>
    <email>M.naserdrea3@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed A. Abdelhafez, Doctor</last_name>
    <phone>01065889346</phone>
    <email>mohamed.abdelhafez@aun.edu.eg</email>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>MA Abdelreheem</investigator_full_name>
    <investigator_title>Resident doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Angina, Unstable</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- 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/NCT03266289
org study id: 17100301
nct id: NCT03266289
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Primary aim: evaluation of the short term outcome of different techniques used in
      bifurcational coronary arteries intervention regarding major adverse cardiac event (MACE):
      cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis
      and occurrence of Unstable angina (UA) with ECG changes and echo findings in the same target
      vessel in Assiut university Cath. lab.

      Secondary aim: calculation of the percentage of bifurcational coronary arteries intervention
      in Assiut University Cath.lab
IntroductionCoronary artery bifurcation lesions comprise one of the more complex lesion
      subsetsroutinely faced in interventional cardiology, accounting for up to 20% of all
      coronarydiseases treated by percutaneous coronary intervention (PCI) The technical
      difficulties inherent in the treatment of bifurcation lesions, associatedwith their lower
      success and higher complication rates compared with non-bifurcationlesions, have always been
      the object of intense research activity, with publication ofcontemporary studies in the past
      few years contributing significantly to the decisionmaking process.Bifurcation lesions are
      challenging to categorize, since they are variable not only intheir anatomy (location of
      plaque, plaque burden, angle between branches, site ofbifurcation, and size of branches), but
      also in the dynamic anatomic changes duringtreatment caused by dissections and carina shift.
      Despite these challenges complicatingclassification of bifurcation lesions, many definitions
      have been proposed in an effort tounify this common clinical situation. A coronary
      bifurcation lesion is defined as (coronary artery narrowing occurringadjacent to, and/or
      involving, the origin of a significant side branch). A significant sidebranch (SB) is a
      branch that, if lost, can impact the prognosis of the patient. General different
      classifications of coronary bifurcation lesions have been proposed, dueto the variety of
      possible bifurcation lesions, with different technical implications,treatment options, and
      prognosis. The most used, for its simplicity and reproducibility,is the Medina
      classification. This classification is based on the presence or absence ofnarrowing >50% on
      each of the three components of the bifurcation: the main branchproximal (MBP), the main
      branch distal, and the SB. A value of 0 or 1 is assigned toeach of the three segments in the
      following order: MBP, main branch distal, and SB. Forexample, a bifurcation lesion involving
      the MBP and the SB would be defined as 1, 0,1. Seven morphologies are therefore possible.
      Despite being the most usedclassification, the Medina has several limitations, since it does
      not consider the plaqueburden, branch diameter, lesion length, bifurcation angles, the
      presence of ostialdisease, or calcification.

      The goal of percutaneous coronary intervention in bifurcation lesions is tomaximize flow in
      the main branch (MB), maintain flow in the SB, prevent its occlusion,and maximize long-term
      patency. Data about bifurcational lesions percentage and short term outcome of
      differenttechniques used in intervention in our cath lab is still unknown.Aim of the study
observational model: Other
time perspective: Prospective
measure: Primary aim: evaluation of the short term outcome of different techniques used in bifurcational coronary arteries intervention
time frame: 1 year
description: Primary aim: evaluation of the short term outcome of different techniques used in bifurcational coronary arteries intervention regarding major adverse cardiac event (MACE): cardiac death, myocardial infarction, target vessel revascularization, or stent
measure: Secondary aim: calculation of the percentage of bifurcational coronary arteries intervention in Assiut University Cath.lab
time frame: 1 year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Amr A. Youssef, Prof doctor
role: Study Director
affiliation: Assiut University
last name: Mohamed A. Abdelhafez, Doctor
role: Study Director
affiliation: Assiut University
last name: Mohamed A. Abdelreheem, Residant
phone: 01119535430
email: M.naserdrea3@yahoo.com
last name: Mohamed A. Abdelhafez, Doctor
phone: 01065889346
email: mohamed.abdelhafez@aun.edu.eg
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: MA Abdelreheem
investigator title: Resident doctor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Angina, Unstable
mesh term: Infarction