<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/NCT03247855</url>
  </required_header>
  <id_info>
    <org_study_id>17200098</org_study_id>
    <nct_id>NCT03247855</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Multivessel Minimally Invasive Coronary Artery Bypass Graft Surgery</brief_title>
  <official_title>Safety and Efficacy of Multivessel Minimally Invasive Coronary Artery Bypass Graft Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mohammed Farouk Abdel Hafez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      the aim of this study is to evaluate safety and efficacy of multivessel minimally invasive&#xD;
      coronary artery bypass graft surgery through evaluating the possibility of reaching complete&#xD;
      revascularization , the complications during surgery and the outcomes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Minimally invasive direct coronary artery bypass (MIDCAB) grafting can achieve adequate&#xD;
      coronary artery revascularization in a less invasive manner than conventional coronary artery&#xD;
      bypass grafting (CABG). Bypass from the internal mammary artery (IMA) to the left anterior&#xD;
      descending coronary artery (LAD) is an effective technique for the treatment of simple&#xD;
      anterior descending artery disease. This surgery is especially recommended for patients with&#xD;
      multiple lesions that are not suitable for stent stenosis . One of the main advantages of&#xD;
      MIDCAB is that there is no need for cardiac arrest and cardiopulmonary bypass (CPB) transfer&#xD;
      during surgery . MIDCAB patients also benefit from the neurological protection associated&#xD;
      with this minimally invasive procedure . Unlike traditional revascularization techniques,&#xD;
      which are highly invasive due to the use of a large incision (sternotomy) and cardiopulmonary&#xD;
      bypass (CPB), MIDCAB limits invasiveness by operating through a small incision (thoracotomy)&#xD;
      and by operating on the beating heart to avoid the need for CPB . By limiting invasiveness in&#xD;
      these ways, MIDCAB can reduce the risk of complications such as infection and stroke . In&#xD;
      comparison to traditional CABG and off-pump CABG (via a sternotomy), MIDCAB can enhance early&#xD;
      post-operative quality of life and recovery time . Minimally invasive multivessel coronary&#xD;
      surgery-coronary artery bypass grafting (MICS-CABG) through a small thoracotomy has many&#xD;
      advantages over minimally invasive direct coronary artery bypass (MIDCAB). First, MIDCAB is&#xD;
      limited to a single anastomosis of the left internal mammary artery to the left anterior&#xD;
      descending artery (LIMA-LAD). The surgical exposure of MICS-CABG is done more laterally,&#xD;
      leading to reduced risk of costochondral or rib injury. Also, MICS-CABG allows&#xD;
      revascularization with a similar configuration to that of a traditional sternotomy technique,&#xD;
      by direct-vision LIMA harvesting and hand-sewn proximal and distal anastomoses . MICS may be&#xD;
      performed with or without cardiopulmonary bypass (CPB) assistance, but the use of&#xD;
      femorofemoral CPB in multivessel revascularization has shown to be safe, mitigate the&#xD;
      learning curve, prevent conversions, and allows operative time like that of a sternotomy. ].&#xD;
      Other advantages include a diminished need for blood transfusion, decreased surgical site&#xD;
      infection rates, also early return to full physical function .&#xD;
&#xD;
      On the other hand complications include sternotomy conversion and development of left-sided&#xD;
      pleural effusion . Postoperative pain can be an issue early, but it is transient,&#xD;
      controllable, and significantly decreased by the third postoperative day; it is also&#xD;
      associated with an overall improved postoperative pain picture with improved pulmonary&#xD;
      functions . However, unlike sternotomy patients, MICS-CABG patients have no physical&#xD;
      restriction postoperatively, which leads to better independence.&#xD;
&#xD;
      This study aim to evaluate Safety and efficacy of multivessel minimally invasive coronary&#xD;
      artery bypass graft surgery through measuring several factors such as&#xD;
&#xD;
        1. measuring rate of intraoperative complications occurrence&#xD;
&#xD;
        2. measuring rate of intraoperative conversion to open sternotomy&#xD;
&#xD;
        3. measuring amount of post operative bleeding&#xD;
&#xD;
        4. measuring post operative pain&#xD;
&#xD;
        5. measuring rate of reexploration&#xD;
&#xD;
        6. measuring rate of wound infection&#xD;
&#xD;
        7. calculating days of postoperative hospital stay&#xD;
&#xD;
        8. calculating time to regain normal activity&#xD;
&#xD;
      The information gathered from the eligible patients will be entered into a data sheet&#xD;
      containing the variables of interest that will be analyzed later at the end of the study.&#xD;
      This study will not alter the patients' treatment and follow up at our center, by any means.&#xD;
&#xD;
      The following variables will be studied whenever applicable and whenever they are available&#xD;
      in the patients' charts:&#xD;
&#xD;
        1. Demographic data: (Medical Record Number ,Sex ,Age Other comorbidity)&#xD;
&#xD;
        2. Preoperative variables : (chest pain , dyspnea ,ECG findings ,Myocardial markers and&#xD;
           cardiac troponin ,Cardiac Angiography )&#xD;
&#xD;
        3. Operative variables: (Conversion to sternotomy. , Cardiac arrest ,Operation time ,Need&#xD;
           for IABP, CPB ,Need for blood transfusion)&#xD;
&#xD;
        4. Postoperative variables: (Mortality , Bleeding , Pain , Need of reexploration , Hospital&#xD;
           stay , Wound infection , Regain of normal activity , Relief of symptoms , Need for&#xD;
           another revascularization within 6 month)&#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">October 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>measuring rate of intraoperative complications occurrence</measure>
    <time_frame>2 years</time_frame>
    <description>measuring the rate of complications as bleeding , failure of complete revascularization and cardiac arrest during operation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>measuring rate of intraoperative conversion to open sternotomy</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>measuring amount of post operative bleeding</measure>
    <time_frame>2 years</time_frame>
    <description>measuring the amount of bleeding in the drains in 48 hours post operative in cc</description>
  </primary_outcome>
  <primary_outcome>
    <measure>measuring post operative pain</measure>
    <time_frame>2 years</time_frame>
    <description>measuring pain using wong-baker faces pain rating scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>measuring rate of reexploration</measure>
    <time_frame>2 years</time_frame>
    <description>measuring the need of reexploration of the patient due to post operative massive bleeding</description>
  </primary_outcome>
  <primary_outcome>
    <measure>measuring rate of wound infection</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>calculating days of postoperative hospital stay</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>calculating time to regain normal activity</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>Minimal invasive coronary artery bypass graft</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>minimal invasive coronary artery bypass graft surgery</intervention_name>
    <description>coronary artery bypass grafting surgery by using a minimal invasive technique</description>
    <arm_group_label>Minimal invasive coronary artery bypass graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 or more&#xD;
&#xD;
          2. Angiographically Indication for revascularization based upon symptoms of angina and/or&#xD;
             objective evidence of myocardial ischemia&#xD;
&#xD;
          3. Suitable minimally invasive coronary surgery (MICS) candidate for non-emergent first&#xD;
             time, single or multivessel coronary artery bypass grafting (on pump or off pump)&#xD;
&#xD;
          4. Willing and able to provide written informed consent and comply with study&#xD;
             requirements and accepting the need of conversion if needed.&#xD;
&#xD;
          5. Patient is willing to comply with all follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe congestive heart failure (class III or IV according to NYHA, or pulmonary&#xD;
             edema, cardiogenic shock) at the time of enrollment.&#xD;
&#xD;
          2. Prior surgery with the opening of pericardium or pleura.&#xD;
&#xD;
          3. Prior stroke (within 6 months)or more than 6 months if there are substantial&#xD;
             neurological defects.&#xD;
&#xD;
          4. Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization.&#xD;
&#xD;
          5. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g.&#xD;
             valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting).&#xD;
&#xD;
          6. Contraindication to either CABG, MIDCAB or PCI/DES because of a coexisting clinical&#xD;
             condition.&#xD;
&#xD;
          7. Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding&#xD;
             diathesis.&#xD;
&#xD;
          8. Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine&#xD;
&#xD;
          9. Extra-cardiac illness that is expected to limit survival to less than 5 years e.g.&#xD;
             oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or&#xD;
             significant hepatic failure, severe renal disease.&#xD;
&#xD;
         10. Suspected pregnancy. A pregnancy test will be administered prerandomization to all&#xD;
             women of child-bearing age.&#xD;
&#xD;
         11. Patient inaccessible for follow-up visits required by protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohammed Farouk Abdel Hafez</investigator_full_name>
    <investigator_title>assistant lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</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/NCT03247855
org study id: 17200098
nct id: NCT03247855
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the aim of this study is to evaluate safety and efficacy of multivessel minimally invasive
      coronary artery bypass graft surgery through evaluating the possibility of reaching complete
      revascularization , the complications during surgery and the outcomes
Minimally invasive direct coronary artery bypass (MIDCAB) grafting can achieve adequate
      coronary artery revascularization in a less invasive manner than conventional coronary artery
      bypass grafting (CABG). Bypass from the internal mammary artery (IMA) to the left anterior
      descending coronary artery (LAD) is an effective technique for the treatment of simple
      anterior descending artery disease. This surgery is especially recommended for patients with
      multiple lesions that are not suitable for stent stenosis . One of the main advantages of
      MIDCAB is that there is no need for cardiac arrest and cardiopulmonary bypass (CPB) transfer
      during surgery . MIDCAB patients also benefit from the neurological protection associated
      with this minimally invasive procedure . Unlike traditional revascularization techniques,
      which are highly invasive due to the use of a large incision (sternotomy) and cardiopulmonary
      bypass (CPB), MIDCAB limits invasiveness by operating through a small incision (thoracotomy)
      and by operating on the beating heart to avoid the need for CPB . By limiting invasiveness in
      these ways, MIDCAB can reduce the risk of complications such as infection and stroke . In
      comparison to traditional CABG and off-pump CABG (via a sternotomy), MIDCAB can enhance early
      post-operative quality of life and recovery time . Minimally invasive multivessel coronary
      surgery-coronary artery bypass grafting (MICS-CABG) through a small thoracotomy has many
      advantages over minimally invasive direct coronary artery bypass (MIDCAB). First, MIDCAB is
      limited to a single anastomosis of the left internal mammary artery to the left anterior
      descending artery (LIMA-LAD). The surgical exposure of MICS-CABG is done more laterally,
      leading to reduced risk of costochondral or rib injury. Also, MICS-CABG allows
      revascularization with a similar configuration to that of a traditional sternotomy technique,
      by direct-vision LIMA harvesting and hand-sewn proximal and distal anastomoses . MICS may be
      performed with or without cardiopulmonary bypass (CPB) assistance, but the use of
      femorofemoral CPB in multivessel revascularization has shown to be safe, mitigate the
      learning curve, prevent conversions, and allows operative time like that of a sternotomy. ].
      Other advantages include a diminished need for blood transfusion, decreased surgical site
      infection rates, also early return to full physical function .

      On the other hand complications include sternotomy conversion and development of left-sided
      pleural effusion . Postoperative pain can be an issue early, but it is transient,
      controllable, and significantly decreased by the third postoperative day; it is also
      associated with an overall improved postoperative pain picture with improved pulmonary
      functions . However, unlike sternotomy patients, MICS-CABG patients have no physical
      restriction postoperatively, which leads to better independence.

      This study aim to evaluate Safety and efficacy of multivessel minimally invasive coronary
      artery bypass graft surgery through measuring several factors such as

        1. measuring rate of intraoperative complications occurrence

        2. measuring rate of intraoperative conversion to open sternotomy

        3. measuring amount of post operative bleeding

        4. measuring post operative pain

        5. measuring rate of reexploration

        6. measuring rate of wound infection

        7. calculating days of postoperative hospital stay

        8. calculating time to regain normal activity

      The information gathered from the eligible patients will be entered into a data sheet
      containing the variables of interest that will be analyzed later at the end of the study.
      This study will not alter the patients' treatment and follow up at our center, by any means.

      The following variables will be studied whenever applicable and whenever they are available
      in the patients' charts:

        1. Demographic data: (Medical Record Number ,Sex ,Age Other comorbidity)

        2. Preoperative variables : (chest pain , dyspnea ,ECG findings ,Myocardial markers and
           cardiac troponin ,Cardiac Angiography )

        3. Operative variables: (Conversion to sternotomy. , Cardiac arrest ,Operation time ,Need
           for IABP, CPB ,Need for blood transfusion)

        4. Postoperative variables: (Mortality , Bleeding , Pain , Need of reexploration , Hospital
           stay , Wound infection , Regain of normal activity , Relief of symptoms , Need for
           another revascularization within 6 month)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: measuring rate of intraoperative complications occurrence
time frame: 2 years
description: measuring the rate of complications as bleeding , failure of complete revascularization and cardiac arrest during operation
measure: measuring rate of intraoperative conversion to open sternotomy
time frame: 2 years
measure: measuring amount of post operative bleeding
time frame: 2 years
description: measuring the amount of bleeding in the drains in 48 hours post operative in cc
measure: measuring post operative pain
time frame: 2 years
description: measuring pain using wong-baker faces pain rating scale
measure: measuring rate of reexploration
time frame: 2 years
description: measuring the need of reexploration of the patient due to post operative massive bleeding
measure: measuring rate of wound infection
time frame: 2 years
measure: calculating days of postoperative hospital stay
time frame: 2 years
measure: calculating time to regain normal activity
time frame: 2 years
arm group label: Minimal invasive coronary artery bypass graft
arm group type: Other
intervention type: Procedure
intervention name: minimal invasive coronary artery bypass graft surgery
description: coronary artery bypass grafting surgery by using a minimal invasive technique
arm group label: Minimal invasive coronary artery bypass graft
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Mohammed Farouk Abdel Hafez
investigator title: assistant lecturer
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease