<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/NCT04444999</url>
  </required_header>
  <id_info>
    <org_study_id>MD.19.11.248 - 2019/11/01</org_study_id>
    <nct_id>NCT04444999</nct_id>
  </id_info>
  <brief_title>Carbon Dioxide Guided Angiography in Endovascular Abdominal Aortic Aneurysm Repair</brief_title>
  <official_title>Carbon Dioxide Guided Angiography in Endovascular Abdominal Aortic Aneurysm Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura 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>
      Endovascular aneurysm repair (EVAR) has lower short-term morbidity and mortality than open&#xD;
      surgery. Intra-arterial contrast agents are an important component of successful EVAR as the&#xD;
      tool of choice for preoperative evaluation of aortic aneurysm morphology as well as precise&#xD;
      sizing and intraoperative visualization of the ostia of the renal and hypogastric arteries&#xD;
      for graft replacement. Although iodinated contrast (IC) is overwhelmingly the most common&#xD;
      contrast agent, the perioperative use of IC agents is not recommended in patients with renal&#xD;
      dysfunction or allergies to IC The aim of this study was to evaluate feasibility, efficacy&#xD;
      and safety of carbon dioxide (CO2) digital subtraction angiography (DSA) to guide&#xD;
      endovascular aneurysm repair (EVAR) in a cohort of patients with abdominal aortic aneurysm&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION:&#xD;
&#xD;
      Endovascular aneurysm repair (EVAR) has lower short-term morbidity and mortality than open&#xD;
      surgery. Intra-arterial contrast agents are an important component of successful EVAR as the&#xD;
      tool of choice for preoperative evaluation of aortic aneurysm morphology as well as precise&#xD;
      sizing and intraoperative visualization of the ostia of the renal and hypogastric arteries&#xD;
      for graft replacement. Although iodinated contrast (IC) is overwhelmingly the most common&#xD;
      contrast agent, the perioperative use of IC agents is not recommended in patients with renal&#xD;
      dysfunction or allergies to IC.&#xD;
&#xD;
      Many strategies have been proposed with the aim of reducing IC developed, such as the use of&#xD;
      intravascular ultrasound, high-quality 3-dimensional imaging techniques, and fusion of&#xD;
      preoperative and intraoperative imaging. However, despite reports of various methods of renal&#xD;
      protection, including the use of perioperative hydration, acetylcysteine, mannitol, dopamine,&#xD;
      and fenoldopam, the effects of these methods are controversial.&#xD;
&#xD;
      Carbon dioxide (CO2)-guided angiography is an alternative contrast approach first described&#xD;
      for diagnostic purposes by Hawkins. Although many studies have demonstrated the safety and&#xD;
      effectiveness of CO2-EVAR and its noninferiority to Iodinated Contrast Angiography during&#xD;
      EVAR.&#xD;
&#xD;
      Intravascular ultrasound (IVUS) has been used as an alternative to IACA(intra-arterial&#xD;
      contrast agents). Originally, IVUS images had low accuracy, but recent improvements have&#xD;
      resulted in very high-quality images of intra-aortic structures, which makes the use of&#xD;
      IACA(intra-arterial contrast agents) almost unnecessary. An additional advantage of IVUS is&#xD;
      that it facilitates the precise placement of stent grafts, because it is more accurate in&#xD;
      locating hypogastric arteries and renal arteries which have parallax from the anteroposterior&#xD;
      (A-P) view rather than from angiography. In this study, investigators will compare Carbon&#xD;
      Dioxide Guided Angiography in relation to Iodinated Contrast Angiography during EVAR.&#xD;
&#xD;
      Aim of the work The aim of this study was to evaluate feasibility, efficacy and safety of&#xD;
      carbon dioxide (CO2) digital subtraction angiography (DSA) to guide endovascular aneurysm&#xD;
      repair (EVAR) in a cohort of patients with abdominal aortic aneurysm.&#xD;
&#xD;
      Outcome Primary outcomes: Validity of CO2 in Visualizing of Renal and hypogastric arteries.&#xD;
      Neck of the aneurysm measurements. Endoleaks Secondary outcomes: Safety of CO2&#xD;
&#xD;
      Patients and methods Study location: The study will be conducted at the department of&#xD;
      vascular surgery in Mansoura university hospitals Study population: The study will be&#xD;
      conducted in patients with Abdominal Aortic Aneurysm.&#xD;
&#xD;
      Type of the study: Evaluation of diagnostic imaging. Duration of therapy: Two year 2019-2021.&#xD;
      Sample size: It will include all patients presented to our department fulfilling the&#xD;
      inclusion criteria; sample size will be 50 patients.&#xD;
&#xD;
      n=(Z^2 p(1-p))/d^2 Where: Z= 1.96 at 95% confidence level, P= expected prevalence, d=&#xD;
      precision (margin of error) Inclusion criteria Age 18 years old. Less than 50 years old&#xD;
      Abdominal Aortic above Aneurysm candidate for EVAR. Exclusion criteria: previous abdominal&#xD;
      aortic surgery, , mycotic aneurysm and secondary intervention.&#xD;
&#xD;
      Data collection: The demographics, Symptoms and preoperative clinical data will be collected&#xD;
      Consent: Patients after signing informed consent that possible complication from the&#xD;
      procedure ought to happen and what are the alternatives.&#xD;
&#xD;
      Technique:&#xD;
&#xD;
      All procedures are performed using two angiographic methods in each procedure: automated&#xD;
      conventional ICM digital subtraction angiography (DSA) and CO2 automated DSA, in a Philips&#xD;
      hybrid operating theatre. IVUS method (instead of ICM) will be used in chronc kidney disease&#xD;
      patients Proximal and distal sealing zone are evaluated before and after endograft&#xD;
      deployment, for diagnostic and completion evaluation respectively, by both imaging methods.&#xD;
&#xD;
      The presence of endoleaks will be also evaluated at the completion angiography, by both&#xD;
      methods.&#xD;
&#xD;
      The angiographic results that will be obtained by CO2 and ICM will be compared. Preoperative&#xD;
      imaging will be performed by contrast enhanced computed tomography (CTA); analyzed with&#xD;
      dedicated software for vessels analysis. centerline will be manually calculated by selecting&#xD;
      points at the center of aorta and iliac arteries using multi planar reconstructions (axial,&#xD;
      sagittal and coronal views).&#xD;
&#xD;
      Abdominal aortic aneurysm volumetric evaluation is performed by selecting points of the&#xD;
      external aortic wall (AAA total volume) and of the internal aortic lumen (AAA true luminal&#xD;
      volume) from the lower renal artery to the aortic bifurcation, using a dedicated software of&#xD;
      volumetric CTA analysis (3MensioTM).&#xD;
&#xD;
      Conventional contrast media angiography: Iodinate contrast media DSA will be performed by&#xD;
      automatic and manual injection. For the automatic DSA, isotonic ICM is injected trough a&#xD;
      pigtail catheter (5F/65 mm length) positioned just above the renal arteries, using automated&#xD;
      injector. During each procedure two automated ICM DSA, with a volume of 20 mL at a rate of 14&#xD;
      mL/s, are performed: a diagnostic injection before the deployment of the endograft, in order&#xD;
      to visualize the proximal sealing zone, the aortic bifurcation and the distal sealing zone,&#xD;
      and a completion angiography to confirm the technical success and to evaluate the presence of&#xD;
      endoleaks. Manual retrograde injections (3 mL ICM each) are performed from the femoral access&#xD;
      by 10 F /11mm length sheet to visualize the hypogastric arteries origin and confirm the&#xD;
      distal sealing zone just before the limb deployment.&#xD;
&#xD;
      Intravascular ultrasound (IVUS) will have been used as an alternative to iodinated contrast&#xD;
      in if the iodinated contrast contraindicated patients. The IVUS procedure steps used are&#xD;
      summarized here.&#xD;
&#xD;
      First, the bilateral common femoral arteries were exposed and a 9-F sheath introducer the&#xD;
      lowest profile adjusted to the 8.2-F of the outer diameter of the IVUS transducer is inserted&#xD;
      retrograde. A soft guidewire is used to introduce a calibrated pigtail catheter, graduated in&#xD;
      centimetres, up to the thoracic aortic arch. The guidewire is then replaced with a stiff wire&#xD;
      followed by IVUS insertion. IVUS is used to locate the renal arteries and hypogastric&#xD;
      arteries by mapping them on the monitor; then, IVUS is switched to the calibrated catheter to&#xD;
      determine the length of the main body.&#xD;
&#xD;
      IVUS is introduced using the monorail system. After deployment of the main body, the soft&#xD;
      guidewire is cannulated into the contralateral limb. The guidewire is replaced with the stiff&#xD;
      wire, followed by the IVUS insertion. The length of the contralateral site is determined by&#xD;
      measuring the length from the edge of the main body to the site of the hypogastric ostium.&#xD;
      Using the same technique, investigators will estimate the stent graft length with the&#xD;
      calibrated catheter. Automated carbon dioxide angiography: Patients are placed in the&#xD;
      Trendelenburg position with the feet elevated of 10 º degrees. Carbon Dioxide automatic&#xD;
      injection will be performed by digital Angiodroid injection system (Angiodroid SRL, San&#xD;
      Lazzaro, Bologna, Italy) connected to the sidearm of 10F/11mm length sheet. Ten milliliters&#xD;
      of CO2 are infused to fill the tubing with gas and eliminate the air. Then by apposite&#xD;
      manipulation of the stopcocks, the sheath is back-bled through its sidearm, and CO2 infused,&#xD;
      creating a blood-CO2 interface with no air in the system 12. The 10F sheet is positioned at&#xD;
      the level of the external iliac artery at the contralateral access of the main body. Each&#xD;
      injection volume will be 100 mL of CO2 and the injection pressure is 300 mmHg (Figure 1D). To&#xD;
      avoid gas fragmentation, the catheter will be purged prior to each injection and delivery is&#xD;
      in a continuous controlled fashion. During each procedure a diagnostic evaluation, before the&#xD;
      deployment of the endograft, an angiography to visualize the hypogastric arteries origin and&#xD;
      a completion angiography, is performed after the positioning of the endograft. Both the&#xD;
      endograft deployment angiography and the completion angiography will be performed maintaining&#xD;
      a constant blood systolic pressure, between 100 and 120 mmHg.&#xD;
&#xD;
      Operative technique: All the procedures are performed in a Philips hybrid operating theatre&#xD;
      and all angiograms are obtained using the Integris Allura 12 DSA. Bilateral common femoral&#xD;
      artery access is obtained through surgical cut down under spinal or general anesthesia.&#xD;
      According with the vertebral bone landmarks, identified pre-operatively, the main-body&#xD;
      endograft is advanced up to the juxta-renal aortic segment. An angiographic evaluation is&#xD;
      performed before the endograft deployment. After contra-lateral gate cannulation, a marked&#xD;
      pig tail will be used to measure the iliac limb length and to identify the origin of the&#xD;
      hypogastric artery from the contralateral access. When a trimodular endograft is deployed,&#xD;
      the same maneuver will be performed for the ipsilateral access. Patients considered at high&#xD;
      risk for persistent type II endoleak (ELII) underwent intraoperative AAA sac embolization as&#xD;
      reported in a previous experience. After the endograft deployment a completion angiography is&#xD;
      performed in all cases.&#xD;
&#xD;
      Endpoints and definition Primary endpoints are to determine the efficacy of CO2 automated DSA&#xD;
      in proximal/distal sealing zone evaluation and endoleaks detection, in comparison with ICM.&#xD;
&#xD;
      Secondary endpoint is to evaluate the safety of CO2 standardized automated injection (any&#xD;
      side effects).&#xD;
&#xD;
      Patients are defined fit for standard EVAR when proximal and distal neck length was ≥ 15 mm&#xD;
      and aortic neck β angle and angles at the level of iliac arteries were &lt; 60°.&#xD;
&#xD;
      Diagnostic angiography is defined as the first angiography performed with the main body&#xD;
      advanced at the level of the lower renal artery according to bone landmarks, just before its&#xD;
      deployment, in order to visualize the optimal proximal sealing zone.&#xD;
&#xD;
      The intraoperative proximal sealing zone evaluation is defined effective when the lower renal&#xD;
      artery and the proximal aortic neck just below it, are correctly visualized.&#xD;
&#xD;
      The intraoperative distal sealing zone evaluation is defined effective if the origin of the&#xD;
      hypogastric artery and the distal segment of the common iliac artery just above it, are&#xD;
      visualized.&#xD;
&#xD;
      Technical success (TS) is defined as the complete endograft deployment with patency of renal&#xD;
      and hypogastric arteries, absence of type I/III endoleaks and iliac leg kinking or stenosis,&#xD;
      no conversion to OR or 24-hour mortality. Endoleaks are defined according to White and May&#xD;
      classification .&#xD;
&#xD;
      CO2 side effects (CO2 narcosis) are defined as any adverse events correlate to CO2 automated&#xD;
      injection. As reported in literature, abdominal pain, transient hypotension, nausea, ischemic&#xD;
      colitis occurring intraoperatively or within 30 minutes from the procedure, are considered&#xD;
      adverse events correlate to CO2.&#xD;
&#xD;
      Follow up Every patient will be followed first week and month, then every 3 months For at&#xD;
      least 6 months.&#xD;
&#xD;
      Evaluation made by CTA or duplex ultrasonography&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      The clinical characteristics of the study population is summarized by descriptive statistics.&#xD;
      The following tests Fisher's exact test and the Mann-Whitney U test; used for categorical and&#xD;
      continuous variables, respectively. Sensitivity and specificity will measures of the&#xD;
      performance of the test Individual differences were considered to be statistically&#xD;
      significant at p &lt; 0.05 Continuous data are presented as median and interquartile range&#xD;
      (IQR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</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>
    <intervention_model_description>carbon dioxide (CO2) digital subtraction angiography (DSA) to guide endovascular aneurysm repair (EVAR(</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Validity of Carbon Dioxide angiography in Visualizing of Renal and hypogastric arteries.</measure>
    <time_frame>6 months</time_frame>
    <description>Visualizing of Renal and hypogastric arteries.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validity of Carbon Dioxide angiography in Visualizing Neck of the aneurysm measurements.</measure>
    <time_frame>6 months</time_frame>
    <description>measuring the supra renal and infra renal neck measurements</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validity of Carbon Dioxide angiography in Visualizing Endoleaks</measure>
    <time_frame>6 months</time_frame>
    <description>Endoleaks occur when blood leaks back into an aneurysm sac following an endovascular aneurysm repair (EVAR) procedure-one of the procedure's most common complications.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of Carbon Dioxide angiography at Endovascular aortic aneurysm repair</measure>
    <time_frame>6 months</time_frame>
    <description>Adverse effects of Carbon Dioxide angiography</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Abdominal Aortic Aneurysm</condition>
  <arm_group>
    <arm_group_label>Endovascular abdominal aortic aneurysm repair</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a type of endovascular surgery used to treat pathology of the aorta, most commonly an abdominal aortic aneurysm (AAA).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Carbon Dioxide Angiography</intervention_name>
    <description>• Automated carbon dioxide angiography: Patients are placed in the Trendelenburg position with the feet elevated of 10 º degrees. Carbon Dioxide automatic injection will be performed by digital Angiodroid injection system</description>
    <arm_group_label>Endovascular abdominal aortic aneurysm repair</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age more than 18 years old. Abdominal Aortic above Aneurysm candidate for EVAR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous abdominal aortic surgery, , mycotic aneurysm and secondary intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mosaad A Soliman, P.h.D</last_name>
    <phone>01001535711</phone>
    <phone_ext>002</phone_ext>
    <email>soliman_mosaad@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mansoura</name>
      <address>
        <city>Mansoura</city>
        <state>Mansoura University</state>
        <zip>35111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mansoura UH Hospitals</last_name>
      <phone>0502202876</phone>
      <phone_ext>0200</phone_ext>
      <email>muh@mans.edu.eg</email>
    </contact>
    <contact_backup>
      <last_name>Mansoura UH Hospitals</last_name>
      <phone>050 2202750</phone>
      <phone_ext>0200</phone_ext>
      <email>muh@mans.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>July 16, 2022</last_update_submitted>
  <last_update_submitted_qc>July 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</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/NCT04444999
org study id: MD.19.11.248 - 2019/11/01
nct id: NCT04444999
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endovascular aneurysm repair (EVAR) has lower short-term morbidity and mortality than open
      surgery. Intra-arterial contrast agents are an important component of successful EVAR as the
      tool of choice for preoperative evaluation of aortic aneurysm morphology as well as precise
      sizing and intraoperative visualization of the ostia of the renal and hypogastric arteries
      for graft replacement. Although iodinated contrast (IC) is overwhelmingly the most common
      contrast agent, the perioperative use of IC agents is not recommended in patients with renal
      dysfunction or allergies to IC The aim of this study was to evaluate feasibility, efficacy
      and safety of carbon dioxide (CO2) digital subtraction angiography (DSA) to guide
      endovascular aneurysm repair (EVAR) in a cohort of patients with abdominal aortic aneurysm
INTRODUCTION:

      Endovascular aneurysm repair (EVAR) has lower short-term morbidity and mortality than open
      surgery. Intra-arterial contrast agents are an important component of successful EVAR as the
      tool of choice for preoperative evaluation of aortic aneurysm morphology as well as precise
      sizing and intraoperative visualization of the ostia of the renal and hypogastric arteries
      for graft replacement. Although iodinated contrast (IC) is overwhelmingly the most common
      contrast agent, the perioperative use of IC agents is not recommended in patients with renal
      dysfunction or allergies to IC.

      Many strategies have been proposed with the aim of reducing IC developed, such as the use of
      intravascular ultrasound, high-quality 3-dimensional imaging techniques, and fusion of
      preoperative and intraoperative imaging. However, despite reports of various methods of renal
      protection, including the use of perioperative hydration, acetylcysteine, mannitol, dopamine,
      and fenoldopam, the effects of these methods are controversial.

      Carbon dioxide (CO2)-guided angiography is an alternative contrast approach first described
      for diagnostic purposes by Hawkins. Although many studies have demonstrated the safety and
      effectiveness of CO2-EVAR and its noninferiority to Iodinated Contrast Angiography during
      EVAR.

      Intravascular ultrasound (IVUS) has been used as an alternative to IACA(intra-arterial
      contrast agents). Originally, IVUS images had low accuracy, but recent improvements have
      resulted in very high-quality images of intra-aortic structures, which makes the use of
      IACA(intra-arterial contrast agents) almost unnecessary. An additional advantage of IVUS is
      that it facilitates the precise placement of stent grafts, because it is more accurate in
      locating hypogastric arteries and renal arteries which have parallax from the anteroposterior
      (A-P) view rather than from angiography. In this study, investigators will compare Carbon
      Dioxide Guided Angiography in relation to Iodinated Contrast Angiography during EVAR.

      Aim of the work The aim of this study was to evaluate feasibility, efficacy and safety of
      carbon dioxide (CO2) digital subtraction angiography (DSA) to guide endovascular aneurysm
      repair (EVAR) in a cohort of patients with abdominal aortic aneurysm.

      Outcome Primary outcomes: Validity of CO2 in Visualizing of Renal and hypogastric arteries.
      Neck of the aneurysm measurements. Endoleaks Secondary outcomes: Safety of CO2

      Patients and methods Study location: The study will be conducted at the department of
      vascular surgery in Mansoura university hospitals Study population: The study will be
      conducted in patients with Abdominal Aortic Aneurysm.

      Type of the study: Evaluation of diagnostic imaging. Duration of therapy: Two year 2019-2021.
      Sample size: It will include all patients presented to our department fulfilling the
      inclusion criteria; sample size will be 50 patients.

      n=(Z^2 p(1-p))/d^2 Where: Z= 1.96 at 95% confidence level, P= expected prevalence, d=
      precision (margin of error) Inclusion criteria Age 18 years old. Less than 50 years old
      Abdominal Aortic above Aneurysm candidate for EVAR. Exclusion criteria: previous abdominal
      aortic surgery, , mycotic aneurysm and secondary intervention.

      Data collection: The demographics, Symptoms and preoperative clinical data will be collected
      Consent: Patients after signing informed consent that possible complication from the
      procedure ought to happen and what are the alternatives.

      Technique:

      All procedures are performed using two angiographic methods in each procedure: automated
      conventional ICM digital subtraction angiography (DSA) and CO2 automated DSA, in a Philips
      hybrid operating theatre. IVUS method (instead of ICM) will be used in chronc kidney disease
      patients Proximal and distal sealing zone are evaluated before and after endograft
      deployment, for diagnostic and completion evaluation respectively, by both imaging methods.

      The presence of endoleaks will be also evaluated at the completion angiography, by both
      methods.

      The angiographic results that will be obtained by CO2 and ICM will be compared. Preoperative
      imaging will be performed by contrast enhanced computed tomography (CTA); analyzed with
      dedicated software for vessels analysis. centerline will be manually calculated by selecting
      points at the center of aorta and iliac arteries using multi planar reconstructions (axial,
      sagittal and coronal views).

      Abdominal aortic aneurysm volumetric evaluation is performed by selecting points of the
      external aortic wall (AAA total volume) and of the internal aortic lumen (AAA true luminal
      volume) from the lower renal artery to the aortic bifurcation, using a dedicated software of
      volumetric CTA analysis (3MensioTM).

      Conventional contrast media angiography: Iodinate contrast media DSA will be performed by
      automatic and manual injection. For the automatic DSA, isotonic ICM is injected trough a
      pigtail catheter (5F/65 mm length) positioned just above the renal arteries, using automated
      injector. During each procedure two automated ICM DSA, with a volume of 20 mL at a rate of 14
      mL/s, are performed: a diagnostic injection before the deployment of the endograft, in order
      to visualize the proximal sealing zone, the aortic bifurcation and the distal sealing zone,
      and a completion angiography to confirm the technical success and to evaluate the presence of
      endoleaks. Manual retrograde injections (3 mL ICM each) are performed from the femoral access
      by 10 F /11mm length sheet to visualize the hypogastric arteries origin and confirm the
      distal sealing zone just before the limb deployment.

      Intravascular ultrasound (IVUS) will have been used as an alternative to iodinated contrast
      in if the iodinated contrast contraindicated patients. The IVUS procedure steps used are
      summarized here.

      First, the bilateral common femoral arteries were exposed and a 9-F sheath introducer the
      lowest profile adjusted to the 8.2-F of the outer diameter of the IVUS transducer is inserted
      retrograde. A soft guidewire is used to introduce a calibrated pigtail catheter, graduated in
      centimetres, up to the thoracic aortic arch. The guidewire is then replaced with a stiff wire
      followed by IVUS insertion. IVUS is used to locate the renal arteries and hypogastric
      arteries by mapping them on the monitor; then, IVUS is switched to the calibrated catheter to
      determine the length of the main body.

      IVUS is introduced using the monorail system. After deployment of the main body, the soft
      guidewire is cannulated into the contralateral limb. The guidewire is replaced with the stiff
      wire, followed by the IVUS insertion. The length of the contralateral site is determined by
      measuring the length from the edge of the main body to the site of the hypogastric ostium.
      Using the same technique, investigators will estimate the stent graft length with the
      calibrated catheter. Automated carbon dioxide angiography: Patients are placed in the
      Trendelenburg position with the feet elevated of 10 º degrees. Carbon Dioxide automatic
      injection will be performed by digital Angiodroid injection system (Angiodroid SRL, San
      Lazzaro, Bologna, Italy) connected to the sidearm of 10F/11mm length sheet. Ten milliliters
      of CO2 are infused to fill the tubing with gas and eliminate the air. Then by apposite
      manipulation of the stopcocks, the sheath is back-bled through its sidearm, and CO2 infused,
      creating a blood-CO2 interface with no air in the system 12. The 10F sheet is positioned at
      the level of the external iliac artery at the contralateral access of the main body. Each
      injection volume will be 100 mL of CO2 and the injection pressure is 300 mmHg (Figure 1D). To
      avoid gas fragmentation, the catheter will be purged prior to each injection and delivery is
      in a continuous controlled fashion. During each procedure a diagnostic evaluation, before the
      deployment of the endograft, an angiography to visualize the hypogastric arteries origin and
      a completion angiography, is performed after the positioning of the endograft. Both the
      endograft deployment angiography and the completion angiography will be performed maintaining
      a constant blood systolic pressure, between 100 and 120 mmHg.

      Operative technique: All the procedures are performed in a Philips hybrid operating theatre
      and all angiograms are obtained using the Integris Allura 12 DSA. Bilateral common femoral
      artery access is obtained through surgical cut down under spinal or general anesthesia.
      According with the vertebral bone landmarks, identified pre-operatively, the main-body
      endograft is advanced up to the juxta-renal aortic segment. An angiographic evaluation is
      performed before the endograft deployment. After contra-lateral gate cannulation, a marked
      pig tail will be used to measure the iliac limb length and to identify the origin of the
      hypogastric artery from the contralateral access. When a trimodular endograft is deployed,
      the same maneuver will be performed for the ipsilateral access. Patients considered at high
      risk for persistent type II endoleak (ELII) underwent intraoperative AAA sac embolization as
      reported in a previous experience. After the endograft deployment a completion angiography is
      performed in all cases.

      Endpoints and definition Primary endpoints are to determine the efficacy of CO2 automated DSA
      in proximal/distal sealing zone evaluation and endoleaks detection, in comparison with ICM.

      Secondary endpoint is to evaluate the safety of CO2 standardized automated injection (any
      side effects).

      Patients are defined fit for standard EVAR when proximal and distal neck length was ≥ 15 mm
      and aortic neck β angle and angles at the level of iliac arteries were < 60°.

      Diagnostic angiography is defined as the first angiography performed with the main body
      advanced at the level of the lower renal artery according to bone landmarks, just before its
      deployment, in order to visualize the optimal proximal sealing zone.

      The intraoperative proximal sealing zone evaluation is defined effective when the lower renal
      artery and the proximal aortic neck just below it, are correctly visualized.

      The intraoperative distal sealing zone evaluation is defined effective if the origin of the
      hypogastric artery and the distal segment of the common iliac artery just above it, are
      visualized.

      Technical success (TS) is defined as the complete endograft deployment with patency of renal
      and hypogastric arteries, absence of type I/III endoleaks and iliac leg kinking or stenosis,
      no conversion to OR or 24-hour mortality. Endoleaks are defined according to White and May
      classification .

      CO2 side effects (CO2 narcosis) are defined as any adverse events correlate to CO2 automated
      injection. As reported in literature, abdominal pain, transient hypotension, nausea, ischemic
      colitis occurring intraoperatively or within 30 minutes from the procedure, are considered
      adverse events correlate to CO2.

      Follow up Every patient will be followed first week and month, then every 3 months For at
      least 6 months.

      Evaluation made by CTA or duplex ultrasonography

      Statistical analysis:

      The clinical characteristics of the study population is summarized by descriptive statistics.
      The following tests Fisher's exact test and the Mann-Whitney U test; used for categorical and
      continuous variables, respectively. Sensitivity and specificity will measures of the
      performance of the test Individual differences were considered to be statistically
      significant at p < 0.05 Continuous data are presented as median and interquartile range
      (IQR).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: carbon dioxide (CO2) digital subtraction angiography (DSA) to guide endovascular aneurysm repair (EVAR(
primary purpose: Treatment
masking: None (Open Label)
measure: Validity of Carbon Dioxide angiography in Visualizing of Renal and hypogastric arteries.
time frame: 6 months
description: Visualizing of Renal and hypogastric arteries.
measure: Validity of Carbon Dioxide angiography in Visualizing Neck of the aneurysm measurements.
time frame: 6 months
description: measuring the supra renal and infra renal neck measurements
measure: Validity of Carbon Dioxide angiography in Visualizing Endoleaks
time frame: 6 months
description: Endoleaks occur when blood leaks back into an aneurysm sac following an endovascular aneurysm repair (EVAR) procedure-one of the procedure's most common complications.
measure: Safety of Carbon Dioxide angiography at Endovascular aortic aneurysm repair
time frame: 6 months
description: Adverse effects of Carbon Dioxide angiography
arm group label: Endovascular abdominal aortic aneurysm repair
arm group type: Experimental
description: a type of endovascular surgery used to treat pathology of the aorta, most commonly an abdominal aortic aneurysm (AAA).
intervention type: Procedure
intervention name: Carbon Dioxide Angiography
description: • Automated carbon dioxide angiography: Patients are placed in the Trendelenburg position with the feet elevated of 10 º degrees. Carbon Dioxide automatic injection will be performed by digital Angiodroid injection system
arm group label: Endovascular abdominal aortic aneurysm repair
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mosaad A Soliman, P.h.D
phone: 01001535711
phone ext: 002
email: soliman_mosaad@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal
sharing ipd: No