<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/NCT04458714</url>
  </required_header>
  <id_info>
    <org_study_id>zu-irb#6036/16-3-2015</org_study_id>
    <nct_id>NCT04458714</nct_id>
  </id_info>
  <brief_title>Carbon Dioxide Versus Iodine Contrast for Endovascular Revascularization of Aortoiliac Occlusive Disease</brief_title>
  <official_title>Carbon Dioxide Versus Iodine Contrast Medium for Endovascular Revascularization of Aortoiliac Occlusive Disease: A Two Center Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig 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>
      From July 2015 to July 2018, 64 patients with aortoiliac occlusive disease who were eligible&#xD;
      for endovascular treatment and lacked contraindications to either iodine contrast or carbon&#xD;
      dioxide (CO2) were randomized into the carbon dioxide CO2 group(32) or iodine contrast&#xD;
      medium(ICM) group(32) were subjected to aortoiliac angioplasty. The primary outcome was the&#xD;
      quality of image as the sole contrast agent used in interventions. The secondary outcomes&#xD;
      were technical success rate and the safety of procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sampling The sample size was calculated by the intuitional review board statistician using&#xD;
      open epi based on the RCT done by Mendes et al. Power of study as set at 80% and confidence&#xD;
      interval set at 95%. The sample size was calculated to be 64 cases, 32 in each group.&#xD;
&#xD;
      Randomization All patients who qualified for the inclusion and exclusion criteria were&#xD;
      offered to participate in the trial after explaining all the details involved with the&#xD;
      potential benefits and risks of both contrast mediums. Patients who agreed were asked to sign&#xD;
      an informed consent. After patient data input was done, randomization was computer generated&#xD;
      in the vascular surgery department in Zagazig university hospitals. Computer generated random&#xD;
      numbers were created with the use of randomly permuted blocks with two block sizes; after&#xD;
      which they were secured in consecutive numbered envelopes and group allocation was&#xD;
      independent of time and person delivering the treatment. Single blinding was used to recruit&#xD;
      the patients. The patients were randomized into the following two arms: a CO2 group&#xD;
      (treatment arm) and an ICM group (control arm) according to the contrast medium selected for&#xD;
      the intervention. Group I included 32 patients who were randomized for using CO2 as the&#xD;
      contrast medium. Group II: involved 32 patients who were randomized for using iodine contrast&#xD;
      medium (ICM).&#xD;
&#xD;
      Postoperative assessment and follow-up The endovascular equipment used in each intervention&#xD;
      and the volumes of contrast used were accurately documented for analysis. Immediately after&#xD;
      the operation all patients in both arms received intravenous fluids pre and post intervention&#xD;
      following a local guideline for renal protection.¬ Patients were discharged the next day and&#xD;
      outpatient renal functions were repeated 3 days post procedure, 1 week and 1 month. We&#xD;
      analyzed creatinine levels between the two groups during the pre- and post-operative periods.&#xD;
      Any elevation of serum creatinine (Scr) of more than 25% or ≥0.5 mg/dl is defined as contrast&#xD;
      induced nephropathy (CIN). Patients were followed up for 1 year. One patient from the CO2&#xD;
      group decided to withdraw from the trial during the follow up period and was excluded from&#xD;
      the follow up analysis.&#xD;
&#xD;
      Imaging from all cases were analyzed on conclusion of the study. The images were reviewed by&#xD;
      two independent observers (radiologists with &gt; 5 years of experience in performing&#xD;
      endovascular procedures) blinded to treatment arm. Image quality was assessed using Likert&#xD;
      rating scale ranging from 1 (very poor) to 5 (very good) for each image.18 A score of 1 was&#xD;
      defined as poor quality with loss of delineation of the vessel. A score of 2 was considered&#xD;
      below average with poor delineation of the vessel, a score of 3 is for average quality image&#xD;
      and medium delineation of the vessel, a score of 4 was considered good quality with clear&#xD;
      delineation of the vessel and a score of 5 was considered very good quality with very clear&#xD;
      delineation of the vessel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Actual">January 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Patients who agreed were asked to sign an informed consent. After patient data input was done, randomization was computer generated in the vascular surgery department in Zagazig university hospitals. Computer generated random numbers were created with the use of randomly permuted blocks with two block sizes; after which they were secured in consecutive numbered envelopes and group allocation was independent of time and person delivering the treatment. Single blinding was used to recruit the patients.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>quality of image as the sole contrast agent to perform the needed interventions: Likert rating scale</measure>
    <time_frame>on conclusion of patient recruitment , image quality was aseessed within 12 weeks</time_frame>
    <description>Imaging from all cases were analyzed on conclusion of the study. The images were reviewed by two independent observers (radiologists with &gt; 5 years of experience in performing endovascular procedures) blinded to treatment arm. Image quality was assessed using Likert rating scale ranging from 1 (very poor) to 5 (very good) for each image.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>technical success rate</measure>
    <time_frame>immediate post operative</time_frame>
    <description>surgical results with completion of the intended procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Procedure-related complications .</measure>
    <time_frame>1year follow up</time_frame>
    <description>defined as the freedom from procedural complications (Procedure-related complications were the incidence of cardiac death, myocardial infarction, stroke, major amputation, non-occlusive mesenteric ischemia, extended hospitalization (&gt; 24 hours) as a consequence of CO2-guided treatment, hematomas, pseudo-aneurysms, perforations, contrast induced nephropathy (CIN), target lesion revascularization and postoperative death within 3 months of surgery,)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Aortoiliac Occlusive Disease</condition>
  <arm_group>
    <arm_group_label>CO2 group (treatment arm)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm included 32 patients who were randomized for using CO2 as the contrast medium for aortoiliac angiolplasty.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICM group (control arm)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm involved 32 patients who were randomized for using iodine contrast medium (ICM) for aortoiliac angiolplasty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Aortoiliac angioplasty</intervention_name>
    <description>In the CO2 arm we used manual injection of CO2 from a medicinal CO2 cylinder connected to a particle filter. Under water aspiration was used to prevent air contamination. Using a twenty mls syringe the required amount of CO2was aspirated using a three way tap and was followed my aspirating 3mls of saline to provide a fluid barrier. In the ICM arm the injection of contrast was done using 10-ml syringes with 5 mls of iodinated contrast media and 5 mls of saline solution per injection. The ICM used in all cases was Omnipaque 300 (Iohexol), a nonionic low osmolar contrast commonly in use in both hospitals.</description>
    <arm_group_label>CO2 group (treatment arm)</arm_group_label>
    <arm_group_label>ICM group (control arm)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with aortoiliac arteries atherosclerotic disease (with arterial&#xD;
             atherosclerotic disease classified as Trans-Atlantic Inter-Society Consensus (TASC) A,&#xD;
             B and C, (classified by CT angiography)&#xD;
&#xD;
          -  Patients with good distal runoff&#xD;
&#xD;
          -  Patients suitable for either types of contrast ICM or CO2 (No history of allergy to&#xD;
             contrast and normal kidney functions)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with TASC D aortoiliac lesions&#xD;
&#xD;
          -  Patients requiring femoral endartectomy&#xD;
&#xD;
          -  Patient s with significant multilevel distal disease&#xD;
&#xD;
          -  Patients suffering from severe chronic obstructive lung disease, chronic kidney&#xD;
             failure, heart failure, or pregnancy.&#xD;
&#xD;
          -  Patients younger than 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>de Almeida Mendes C, de Arruda Martins A, Teivelis MP, Kuzniec S, Nishinari K, Krutman M, Halpern H, Wolosker N. Carbon dioxide is a cost-effective contrast medium to guide revascularization of TASC A and TASC B femoropopliteal occlusive disease. Ann Vasc Surg. 2014 Aug;28(6):1473-8. doi: 10.1016/j.avsg.2014.03.021. Epub 2014 Apr 3.</citation>
    <PMID>24704050</PMID>
  </reference>
  <reference>
    <citation>Fujihara M, Kawasaki D, Shintani Y, Fukunaga M, Nakama T, Koshida R, Higashimori A, Yokoi Y; CO2 Angiography Registry Investigators. Endovascular therapy by CO2 angiography to prevent contrast-induced nephropathy in patients with chronic kidney disease: a prospective multicenter trial of CO2 angiography registry. Catheter Cardiovasc Interv. 2015 Apr;85(5):870-7. doi: 10.1002/ccd.25722. Epub 2014 Nov 21.</citation>
    <PMID>25380326</PMID>
  </reference>
  <reference>
    <citation>Sharafuddin MJ, Marjan AE. Current status of carbon dioxide angiography. J Vasc Surg. 2017 Aug;66(2):618-637. doi: 10.1016/j.jvs.2017.03.446.</citation>
    <PMID>28735955</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Amro Elboushi</investigator_full_name>
    <investigator_title>associate professorof vascular surgery</investigator_title>
  </responsible_party>
  <keyword>CO2 angiography</keyword>
  <keyword>angioplasty</keyword>
  <keyword>aortoiliac occlusive disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leriche Syndrome</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/NCT04458714
org study id: zu-irb#6036/16-3-2015
nct id: NCT04458714
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
From July 2015 to July 2018, 64 patients with aortoiliac occlusive disease who were eligible
      for endovascular treatment and lacked contraindications to either iodine contrast or carbon
      dioxide (CO2) were randomized into the carbon dioxide CO2 group(32) or iodine contrast
      medium(ICM) group(32) were subjected to aortoiliac angioplasty. The primary outcome was the
      quality of image as the sole contrast agent used in interventions. The secondary outcomes
      were technical success rate and the safety of procedure.
Sampling The sample size was calculated by the intuitional review board statistician using
      open epi based on the RCT done by Mendes et al. Power of study as set at 80% and confidence
      interval set at 95%. The sample size was calculated to be 64 cases, 32 in each group.

      Randomization All patients who qualified for the inclusion and exclusion criteria were
      offered to participate in the trial after explaining all the details involved with the
      potential benefits and risks of both contrast mediums. Patients who agreed were asked to sign
      an informed consent. After patient data input was done, randomization was computer generated
      in the vascular surgery department in Zagazig university hospitals. Computer generated random
      numbers were created with the use of randomly permuted blocks with two block sizes; after
      which they were secured in consecutive numbered envelopes and group allocation was
      independent of time and person delivering the treatment. Single blinding was used to recruit
      the patients. The patients were randomized into the following two arms: a CO2 group
      (treatment arm) and an ICM group (control arm) according to the contrast medium selected for
      the intervention. Group I included 32 patients who were randomized for using CO2 as the
      contrast medium. Group II: involved 32 patients who were randomized for using iodine contrast
      medium (ICM).

      Postoperative assessment and follow-up The endovascular equipment used in each intervention
      and the volumes of contrast used were accurately documented for analysis. Immediately after
      the operation all patients in both arms received intravenous fluids pre and post intervention
      following a local guideline for renal protection.¬ Patients were discharged the next day and
      outpatient renal functions were repeated 3 days post procedure, 1 week and 1 month. We
      analyzed creatinine levels between the two groups during the pre- and post-operative periods.
      Any elevation of serum creatinine (Scr) of more than 25% or ≥0.5 mg/dl is defined as contrast
      induced nephropathy (CIN). Patients were followed up for 1 year. One patient from the CO2
      group decided to withdraw from the trial during the follow up period and was excluded from
      the follow up analysis.

      Imaging from all cases were analyzed on conclusion of the study. The images were reviewed by
      two independent observers (radiologists with > 5 years of experience in performing
      endovascular procedures) blinded to treatment arm. Image quality was assessed using Likert
      rating scale ranging from 1 (very poor) to 5 (very good) for each image.18 A score of 1 was
      defined as poor quality with loss of delineation of the vessel. A score of 2 was considered
      below average with poor delineation of the vessel, a score of 3 is for average quality image
      and medium delineation of the vessel, a score of 4 was considered good quality with clear
      delineation of the vessel and a score of 5 was considered very good quality with very clear
      delineation of the vessel.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Patients who agreed were asked to sign an informed consent. After patient data input was done, randomization was computer generated in the vascular surgery department in Zagazig university hospitals. Computer generated random numbers were created with the use of randomly permuted blocks with two block sizes; after which they were secured in consecutive numbered envelopes and group allocation was independent of time and person delivering the treatment. Single blinding was used to recruit the patients.
measure: quality of image as the sole contrast agent to perform the needed interventions: Likert rating scale
time frame: on conclusion of patient recruitment , image quality was aseessed within 12 weeks
description: Imaging from all cases were analyzed on conclusion of the study. The images were reviewed by two independent observers (radiologists with > 5 years of experience in performing endovascular procedures) blinded to treatment arm. Image quality was assessed using Likert rating scale ranging from 1 (very poor) to 5 (very good) for each image.
measure: technical success rate
time frame: immediate post operative
description: surgical results with completion of the intended procedure.
measure: Incidence of Procedure-related complications .
time frame: 1year follow up
description: defined as the freedom from procedural complications (Procedure-related complications were the incidence of cardiac death, myocardial infarction, stroke, major amputation, non-occlusive mesenteric ischemia, extended hospitalization (> 24 hours) as a consequence of CO2-guided treatment, hematomas, pseudo-aneurysms, perforations, contrast induced nephropathy (CIN), target lesion revascularization and postoperative death within 3 months of surgery,)
arm group label: CO2 group (treatment arm)
arm group type: Active Comparator
description: This arm included 32 patients who were randomized for using CO2 as the contrast medium for aortoiliac angiolplasty.
arm group label: ICM group (control arm)
arm group type: Active Comparator
description: This arm involved 32 patients who were randomized for using iodine contrast medium (ICM) for aortoiliac angiolplasty.
intervention type: Procedure
intervention name: Aortoiliac angioplasty
description: In the CO2 arm we used manual injection of CO2 from a medicinal CO2 cylinder connected to a particle filter. Under water aspiration was used to prevent air contamination. Using a twenty mls syringe the required amount of CO2was aspirated using a three way tap and was followed my aspirating 3mls of saline to provide a fluid barrier. In the ICM arm the injection of contrast was done using 10-ml syringes with 5 mls of iodinated contrast media and 5 mls of saline solution per injection. The ICM used in all cases was Omnipaque 300 (Iohexol), a nonionic low osmolar contrast commonly in use in both hospitals.
arm group label: CO2 group (treatment arm)
arm group label: ICM group (control arm)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
citation: de Almeida Mendes C, de Arruda Martins A, Teivelis MP, Kuzniec S, Nishinari K, Krutman M, Halpern H, Wolosker N. Carbon dioxide is a cost-effective contrast medium to guide revascularization of TASC A and TASC B femoropopliteal occlusive disease. Ann Vasc Surg. 2014 Aug;28(6):1473-8. doi: 10.1016/j.avsg.2014.03.021. Epub 2014 Apr 3.
PMID: 24704050
citation: Fujihara M, Kawasaki D, Shintani Y, Fukunaga M, Nakama T, Koshida R, Higashimori A, Yokoi Y; CO2 Angiography Registry Investigators. Endovascular therapy by CO2 angiography to prevent contrast-induced nephropathy in patients with chronic kidney disease: a prospective multicenter trial of CO2 angiography registry. Catheter Cardiovasc Interv. 2015 Apr;85(5):870-7. doi: 10.1002/ccd.25722. Epub 2014 Nov 21.
PMID: 25380326
citation: Sharafuddin MJ, Marjan AE. Current status of carbon dioxide angiography. J Vasc Surg. 2017 Aug;66(2):618-637. doi: 10.1016/j.jvs.2017.03.446.
PMID: 28735955
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Amro Elboushi
investigator title: associate professorof vascular surgery
mesh term: Leriche Syndrome
sharing ipd: No