<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/NCT01683474</url>
  </required_header>
  <id_info>
    <org_study_id>Venus-A Study</org_study_id>
    <nct_id>NCT01683474</nct_id>
  </id_info>
  <brief_title>Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis</brief_title>
  <acronym>Venus-A</acronym>
  <official_title>Clinical Evaluation of the Safety and Performance of Percutaneous Implantation of the Venus MedTech Aortic Valve Prosthesis for Patients Who Cannot Undergo Surgical Valve Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Venus MedTech (HangZhou) Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Venus MedTech (HangZhou) Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. objectives&#xD;
&#xD;
             -  Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by&#xD;
                femoral artery&#xD;
&#xD;
             -  Evaluate safety and clinical benefit of percutaneous implantation of the Venue&#xD;
                MedTech aortic valve prosthesis.&#xD;
&#xD;
             -  Continuous observe 12 months of safety and efficacy.&#xD;
&#xD;
        2. Approximately 80 patients presenting with native aortic valve stenosis necessitating&#xD;
           valve replacement which are considered unsuitable for Surgical Valve Replacement, with a&#xD;
           high surgical risk, as attested to by both the surgeon and the cardiologist are&#xD;
           recruited in the study.&#xD;
&#xD;
        3. Safety and performance will be evaluated at discharge and at 30 days post procedure.&#xD;
           Valve safety, performance and placement will be followed up at 6 and 12 months&#xD;
           post-procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective OPC study to evaluate its performance and long-term safety and effectiveness of&#xD;
      Venus-A aortic valve.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">April 2016</completion_date>
  <primary_completion_date type="Anticipated">February 2016</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>All cause mortality and major stroke at 12 months post-procedure.</measure>
    <time_frame>12 months post-procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Valve performance and placement at 6 and 12 months post-procedure</measure>
    <time_frame>6 and 12 months post-procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <condition>Aortic Valve Calcification</condition>
  <arm_group>
    <arm_group_label>Venus A-Valve</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single arm with intervention that percutaneous implantation of the Venus MedTech Aortic Valve Prosthesis</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Venus MedTech Aortic Valve Prosthesis</intervention_name>
    <description>Percutaneous implantation of aortic valve of Venus-A</description>
    <arm_group_label>Venus A-Valve</arm_group_label>
    <other_name>Venus A-Valve</other_name>
    <other_name>Venus A-Valve System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean&#xD;
             gradient ≥ 40 mm Hg, or jet velocity ≥ 4.0 m/s, or an aortic valve area (AVA) of &lt; 0.8&#xD;
             cm2 (or AVA index &lt; 0.5 cm2/m2)&#xD;
&#xD;
          -  Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class ≥ II&#xD;
&#xD;
          -  The subject or the subject's legal representative was informed of the nature of the&#xD;
             study, agreed to its provisions and provided written informed consent as approved by&#xD;
             the Institutional Review Board of the respective clinical site.&#xD;
&#xD;
          -  The subject agreed to comply follow-up evaluation&#xD;
&#xD;
          -  is evaluated by at least one cardiologist and two cardiovascular surgeon, and they&#xD;
             agreed that medical factors precluding operation suitable for surgery (the probability&#xD;
             of death or serious, irreversible morbidity exceeded 50%)&#xD;
&#xD;
          -  STS score ≥ 10%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refuses aortic valve replacement surgery.&#xD;
&#xD;
          -  Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment&#xD;
             [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice&#xD;
             normal in the presence of MB elevation and/or troponin level elevation (WHO&#xD;
             definition)].&#xD;
&#xD;
          -  Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is&#xD;
             non-calcified.&#xD;
&#xD;
          -  Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant&#xD;
             aortic regurgitation &gt;3+).&#xD;
&#xD;
          -  Any therapeutic invasive cardiac procedure resulting in a permanent implant that is&#xD;
             performed within 30 days （6 month if DES implant）&#xD;
&#xD;
          -  Implanted any heart valve prosthesis, prosthetic valve ring, severe mitral valve ring&#xD;
             calcification (MAC), severe（&gt;3＋）mitral valve insufficiency, or Gorelin symptom&#xD;
&#xD;
          -  Blood dyscrasia such as leukopenia (WBC &lt; 3×109/L), acute anemia (Hgb &lt; 90 g/L),&#xD;
             thrombocytopenia (PLT &lt; 50×109/L), bleeding diathesis, or history of coagulopathy.&#xD;
&#xD;
          -  Untreated clinically significant coronary artery disease requiring revascularization&#xD;
&#xD;
          -  Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support&#xD;
             devices&#xD;
&#xD;
          -  Need for emergency surgery for any reason&#xD;
&#xD;
          -  Hypertrophic cardiomyopathy with or without obstruction (HOCM)&#xD;
&#xD;
          -  Severe ventricular dysfunction with LVEF &lt; 20%&#xD;
&#xD;
          -  Echocardiographic evidence of intracardiac mass, thrombus or vegetation&#xD;
&#xD;
          -  Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months&#xD;
&#xD;
          -  A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine,&#xD;
             clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately&#xD;
             pre-medicated.&#xD;
&#xD;
          -  Native aortic annulus size &lt; 20 mm or&gt; 29 mm as measured by echocardiogram.&#xD;
&#xD;
          -  Cerebrovascular Accident (CVA) within 6 months, including TIA.&#xD;
&#xD;
          -  Renal insufficiency (creatinine &gt; 3.0 mg/dL) and/or end stage renal disease requiring&#xD;
             chronic dialysis.&#xD;
&#xD;
          -  Life expectancy &lt; 12 months&#xD;
&#xD;
          -  Significant abdominal or thoracic aorta disease, including aneurysm (defined as&#xD;
             maximal luminal diameter 5cm or greater), marked tortuosity (hyperacute bend), aortic&#xD;
             arch atheroma (especially if thick [&gt; 5 mm], protruding or ulcerated), narrowing of&#xD;
             the abdominal aorta (especially with calcification and surface irregularities), or&#xD;
             severe &quot;unfolding&quot; and tortuosity of the thoracic aorta&#xD;
&#xD;
          -  Iliofemoral vessel characteristics that would preclude safe placement of 16F or 18F&#xD;
             introducer sheath such as severe obstructive calcification, severe tortuosity or&#xD;
             vessel size diameter &lt; 7 mm.&#xD;
&#xD;
          -  Currently participating in an investigational drug or another device study.&#xD;
&#xD;
          -  Active bacterial endocarditis or other active infections.&#xD;
&#xD;
          -  Bulky calcified aortic valve leaflets in close proximity to coronary ostia&#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>Ruilin Gao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fuwai Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Runlin Gao, MD</last_name>
    <phone>88398866</phone>
    <phone_ext>8266</phone_ext>
    <email>gaorunlin4study@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fu Wai Hospital, CAMS &amp; PUMA</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Runlin Gao, MD</last_name>
      <email>gaorunlin4study@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Runlin Gao, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>January 3, 2015</last_update_submitted>
  <last_update_submitted_qc>January 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>aortic valve stenosis</keyword>
  <keyword>Calcification</keyword>
  <keyword>TAVI</keyword>
  <keyword>aortic valve Prosthesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Calcinosis</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/NCT01683474
org study id: Venus-A Study
nct id: NCT01683474
lead sponsor: 
has dmc: Yes
1. objectives

             -  Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by
                femoral artery

             -  Evaluate safety and clinical benefit of percutaneous implantation of the Venue
                MedTech aortic valve prosthesis.

             -  Continuous observe 12 months of safety and efficacy.

        2. Approximately 80 patients presenting with native aortic valve stenosis necessitating
           valve replacement which are considered unsuitable for Surgical Valve Replacement, with a
           high surgical risk, as attested to by both the surgeon and the cardiologist are
           recruited in the study.

        3. Safety and performance will be evaluated at discharge and at 30 days post procedure.
           Valve safety, performance and placement will be followed up at 6 and 12 months
           post-procedure.
A prospective OPC study to evaluate its performance and long-term safety and effectiveness of
      Venus-A aortic valve.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All cause mortality and major stroke at 12 months post-procedure.
time frame: 12 months post-procedure
measure: Valve performance and placement at 6 and 12 months post-procedure
time frame: 6 and 12 months post-procedure
arm group label: Venus A-Valve
arm group type: Experimental
description: single arm with intervention that percutaneous implantation of the Venus MedTech Aortic Valve Prosthesis
intervention type: Device
intervention name: Venus MedTech Aortic Valve Prosthesis
description: Percutaneous implantation of aortic valve of Venus-A
arm group label: Venus A-Valve
other name: Venus A-Valve
other name: Venus A-Valve System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ruilin Gao, MD
role: Principal Investigator
affiliation: Fuwai Hospital
last name: Runlin Gao, MD
phone: 88398866
phone ext: 8266
email: gaorunlin4study@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Calcinosis