<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/NCT03252639</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-2016-1.20</org_study_id>
    <nct_id>NCT03252639</nct_id>
  </id_info>
  <brief_title>A Study of Using Parenchymal Blood Volume(PBV) for Endovascular Treatment of Renal Arterial Stenosis</brief_title>
  <official_title>A Prospective Study of Using Parenchymal Blood Volume(PBV) for Endovascular Treatment of Renal Arterial Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      This study will use PBV technique to quantitatively assess the improvement of renal perfusion&#xD;
      before and after endovascular treatment (EVT) of renal artery stenosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: Renal artery stenosis (RAS) is one of the main reasons for secondary hypertension&#xD;
      and renal failure, which etiologies include atherosclerosis, fibromuscular dysplasia and&#xD;
      takayasu arteritis. Endovascular treatment under digital subtraction angiography (DSA) is an&#xD;
      option to treat this disease. However, the technical success of this procedure is mainly&#xD;
      based on morphology of its targeting renal artery without any quantified data towards renal&#xD;
      blood perfusion. Thus, this study will try to solve how renal blood perfusion changes before&#xD;
      and after endovascular treatment of renal artery stenosis.&#xD;
&#xD;
      DESIGN NARRATIVE:&#xD;
&#xD;
      This prospective cohort study will recruit patients with renal artery stenosis. PBV data will&#xD;
      be obtained before and after their endovascular treatments. The volume of target kidney and&#xD;
      its mean density of contrast from PBV data will be calculated as indicators for renal&#xD;
      perfusion. And the relation between the percentage of stenosis and renal perfusion will be&#xD;
      analyzed. The follow-up will last for one year. At 6-month and 12-month follow-up, DSA and&#xD;
      PBV acquisition protocol will be undertaken again to evaluate renal blood perfusion in the&#xD;
      long term.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Kidney Volume</measure>
    <time_frame>15 minutes before endovascular treatment, changes at 15 minutes after endovascular treatment, 6-month and 12-month follow-up respectively.</time_frame>
    <description>the volume of kidney, which is able to indicate total blood volume of kidney, in target kidney</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mean density of contrast</measure>
    <time_frame>15 minutes before endovascular treatment, changes at 15 minutes after endovascular treatment, 6-month and 12-month follow-up respectively.</time_frame>
    <description>the mean density of contrast, which is able to represent renal blood perfusion, in target kidney</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Renal Artery Stenosis</condition>
  <condition>Renal Blood Perfusion</condition>
  <arm_group>
    <arm_group_label>Patients with Renal Artery Stenosis</arm_group_label>
    <description>Patients with renal artery stenosis which may benefit from endovascular treatment will be recruited. Those patients who cannot benefit from this procedure will be excluded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>EVT for RAS &amp; PBV acquisition protocol for target kidneys</intervention_name>
    <arm_group_label>Patients with Renal Artery Stenosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients who meet the inclusion criteria, are willing to join this trial and&#xD;
        treated in the department of vascular surgery, Peking Union Medical College Hospital will&#xD;
        be included in this prospective cohort study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients should meet all of the following criteria:&#xD;
&#xD;
          1. Age ≥ 18.&#xD;
&#xD;
          2. Renal artery stenosis is greater than or equal to 80% and less than 100% by duplex, CT&#xD;
             angiography or magnetic resonance angiography.&#xD;
&#xD;
          3. The target kidney remains functional(tested by radionuclide imaging)&#xD;
&#xD;
          4. Documented history of hypertension on two or more anti-hypertensive medications OR&#xD;
             estimated glomerular filtration rate (eGFR) less than 60 mL per minute per 1.73 m^2,&#xD;
             calculated by the modified Modification of Diet in Renal Disease formula.&#xD;
&#xD;
          5. The length of target kidney is &gt;8cm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients meet any of the following criteria should be excluded.&#xD;
&#xD;
          1. Unable or willing to comply with study protocol or procedures.&#xD;
&#xD;
          2. Pregnancy or lactation.&#xD;
&#xD;
          3. History of kidney transplant.&#xD;
&#xD;
          4. Currently in acute pulmonary edema OR systolic ejection fraction of heart &lt;30% OR&#xD;
             respiratory failure due to hypertension or acute coronary syndrome or cerebrovascular&#xD;
             accident in past 3 months.&#xD;
&#xD;
          5. The eGFR is less than 15 mL per minute per 1.73 m^2 OR serum Cr is greater than 3.0&#xD;
             mg/dl on the day of randomization.&#xD;
&#xD;
          6. Other known reason nonischemic kidney injure(e.g. nephritis). If it is diabetic&#xD;
             nephropathy, 24h urinary protein should be more then 3g.&#xD;
&#xD;
          7. Aorta has stenosis(greater than 30%).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bao Liu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bao Liu, MD</last_name>
    <phone>+86-10-69152502</phone>
    <email>liubao72@aliyun.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bao Liu, MD</last_name>
      <phone>+86-10-69152502</phone>
      <email>liubao72@aliyun.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Renal Artery Stenosis</keyword>
  <keyword>Renal Blood Perfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Artery Obstruction</mesh_term>
    <mesh_term>Constriction, Pathologic</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/NCT03252639
org study id: PUMCH-2016-1.20
nct id: NCT03252639
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will use PBV technique to quantitatively assess the improvement of renal perfusion
      before and after endovascular treatment (EVT) of renal artery stenosis.
BACKGROUND: Renal artery stenosis (RAS) is one of the main reasons for secondary hypertension
      and renal failure, which etiologies include atherosclerosis, fibromuscular dysplasia and
      takayasu arteritis. Endovascular treatment under digital subtraction angiography (DSA) is an
      option to treat this disease. However, the technical success of this procedure is mainly
      based on morphology of its targeting renal artery without any quantified data towards renal
      blood perfusion. Thus, this study will try to solve how renal blood perfusion changes before
      and after endovascular treatment of renal artery stenosis.

      DESIGN NARRATIVE:

      This prospective cohort study will recruit patients with renal artery stenosis. PBV data will
      be obtained before and after their endovascular treatments. The volume of target kidney and
      its mean density of contrast from PBV data will be calculated as indicators for renal
      perfusion. And the relation between the percentage of stenosis and renal perfusion will be
      analyzed. The follow-up will last for one year. At 6-month and 12-month follow-up, DSA and
      PBV acquisition protocol will be undertaken again to evaluate renal blood perfusion in the
      long term.
observational model: Cohort
time perspective: Prospective
measure: Kidney Volume
time frame: 15 minutes before endovascular treatment, changes at 15 minutes after endovascular treatment, 6-month and 12-month follow-up respectively.
description: the volume of kidney, which is able to indicate total blood volume of kidney, in target kidney
measure: mean density of contrast
time frame: 15 minutes before endovascular treatment, changes at 15 minutes after endovascular treatment, 6-month and 12-month follow-up respectively.
description: the mean density of contrast, which is able to represent renal blood perfusion, in target kidney
arm group label: Patients with Renal Artery Stenosis
description: Patients with renal artery stenosis which may benefit from endovascular treatment will be recruited. Those patients who cannot benefit from this procedure will be excluded.
intervention type: Procedure
intervention name: EVT for RAS & PBV acquisition protocol for target kidneys
arm group label: Patients with Renal Artery Stenosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bao Liu, MD
role: Study Director
affiliation: Peking Union Medical College Hospital
last name: Bao Liu, MD
phone: +86-10-69152502
email: liubao72@aliyun.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Renal Artery Obstruction
mesh term: Constriction, Pathologic
sharing ipd: No