xml: <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/NCT06007339</url>
    </required_header>
    <id_info>
      <org_study_id>P934-00</org_study_id>
      <nct_id>NCT06007339</nct_id>
    </id_info>
    <brief_title>PerQseal® Elite Venous Clinical Study (ELITE-Venous)</brief_title>
    <acronym>ELITE-Venous</acronym>
    <official_title>Safety and Performance Study for Venous Large Hole Vascular Closure Device - ELITE Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vivasure Medical Limited</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Vivasure Medical Limited</source>
    <oversight_info>
      <has_dmc>Yes</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 objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite&#xD;
        vascular closure system when used to achieve haemostasis of common femoral venotomies created&#xD;
        by 14 to 22F sheaths (venotomy up to 26F) in patients undergoing percutaneous catheter-based&#xD;
        interventional procedures, with sufficient rigor to provide robust scientific evidence for&#xD;
        the demonstration of clinical safety and efficacy of the PerQseal Elite closure system to&#xD;
        support a CE-mark and a PMA submission.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, multicentre, single-arm study to investigate the safety and&#xD;
        efficacy of the PerQseal Elite in up to 97 patients at up to 12 European investigational&#xD;
        sites. The study shall not be blinded prior to, during or post the procedure. Patients&#xD;
        undergoing a percutaneous catheter-based venous interventional procedure (e.g., mitral valve&#xD;
        repair, leadless pacemaker implantation, circulatory assist or ECMO via large bore femoral&#xD;
        vein catheter) requiring a venotomy created by 14 to 22F sheaths (venotomies up to 26F), via&#xD;
        the common femoral vein will be screened against the study inclusion/exclusion criteria.&#xD;
  &#xD;
        All subjects shall have a 30-minute, 60-minute, pre-discharge (~48 hours), 30-Days ± 7-Days&#xD;
        and 180-Days ± 30-Days follow-up assessments.&#xD;
  &#xD;
        All safety data from the study will be assessed by the Data Safety Monitoring Committee on a&#xD;
        continuous basis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</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>This study is a prospective, multicentre, single-arm study to investigate the safety and efficacy of the PerQseal Elite.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Safety Endpoint- Combined rate of both Major and Minor access site complications</measure>
      <time_frame>through 30 Days</time_frame>
      <description>the combined rate of both Major and Minor access site complications attributable to the PerQseal Elite device§ through 30-days, as adjudicated by the Clinical Events Committee (CEC) as study device related.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Primary Effectiveness Endpoint - Time to Haemostasis</measure>
      <time_frame>20 Minutes</time_frame>
      <description>Time to Haemostasis (TTH) defined as elapsed time in minutes from PerQseal Elite (Introducer-sheath and Delivery-device) removal to first observed cessation of common femoral vein (CFV) bleeding (clinically acceptable cessation of venous bleeding), excluding cutaneous or subcutaneous oozing, and in the absence of a developing haematoma. This is assessed at the end of the index procedure prior leaving the operating room/catheterisation laboratory.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Secondary Effectiveness Endpoint - PerQseal Elite Technical Success Rate</measure>
      <time_frame>10 Minutes</time_frame>
      <description>PerQseal Elite Technical Success Rate is defined as the number of PerQseal Elite devices that are deployed and achieve haemostasis (i.e., cessation of venous bleeding excluding cutaneous or subcutaneous oozing) without need for more than 10 minutes of firm, adjunctive manual compression or alternative treatment (other than adjunctive endovascular ballooning) at target access site, divided by the total number of PerQseal Elite devices where deployment was attempted.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary Effectiveness Endpoint - PerQseal Elite Treatment Success Rate</measure>
      <time_frame>through 30 days</time_frame>
      <description>PerQseal Elite Treatment Success Rate is defined as the number of subjects who meet PerQseal Elite Technical Success without experiencing a device related Access Site Complication (based on CEC adjudication) through 30-days, divided by the total number of subjects where PerQseal Elite device deployment was attempted.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary Effectiveness Endpoint -Time to Device Deployment (TTDD)</measure>
      <time_frame>20 Minutes</time_frame>
      <description>Time to Device Deployment is defined as the time from insertion of the PerQseal Elite delivery device into the PerQseal Elite Introducer sheath to complete removal of the PerQseal Elite (delivery device and introducer-sheath) from the subject following PerQseal Elite deployment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary Effectiveness Endpoint - Time to Ambulation</measure>
      <time_frame>through 24 hours</time_frame>
      <description>Time to Ambulation is defined as: the elapsed time from PerQseal Elite removal from the subject post deployment until the subject can walk 20 feet/6 meters without venous re-bleeding at the target access site. This endpoint will be evaluated only for subjects who are ambulatory (e.g., not confined to wheelchair or bed) at the time of enrolment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary Effectiveness Endpoint - Total Closure Time</measure>
      <time_frame>40 Minutes</time_frame>
      <description>Total Closure Time is defined as: Time to Haemostasis (TTH) plus Time to Device Deployment (TTDD).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Large Hole Percutaneous Venous Closure</condition>
    <arm_group>
      <arm_group_label>Investigational Device Arm (PerQseal Elite- Venous)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Large hole percutaneous venous closure device - PerQseal Elite</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PerQseal ELITE</intervention_name>
      <description>The term PerQseal Elite used singularly refers to the closure system comprising the closure device and Introducer. These individually are referred to as: &quot;PerQseal Elite VCD&quot; or &quot;PerQseal Elite closure device&quot; and/or &quot;PerQseal Elite Introducer&quot;.</description>
      <arm_group_label>Investigational Device Arm (PerQseal Elite- Venous)</arm_group_label>
      <other_name>Percutaneous ELITE Venous Closure Device</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 19 years.&#xD;
  &#xD;
            2. Clinically indicated for a percutaneous venous interventional catheter-based&#xD;
               procedure, e.g., mitral valve edge to edge repair, left atrial appendage device&#xD;
               closure, leadless pacemaker implantation, patent foramen ovale closure or use of a&#xD;
               circulatory assist device or extracorporeal oxygenation using a common femoral&#xD;
               venotomy created by a 14 to 22F sheath (venotomy up to 26F).&#xD;
  &#xD;
            3. Subject is willing and able to provide appropriate study-specific informed consent,&#xD;
               follow protocol procedures, and comply with follow-up visit requirements.&#xD;
  &#xD;
            4. Females who are not pregnant or lactating and not planning to become pregnant for the&#xD;
               duration of the study.&#xD;
  &#xD;
          Baseline Exclusion Criteria:&#xD;
  &#xD;
            1. Evidence of current systemic bacterial or cutaneous infection, including groin&#xD;
               infection,&#xD;
  &#xD;
            2. Known bleeding diathesis, unstable INR, definite or potential coagulopathy, platelet&#xD;
               count &lt; 100,000/μl or subjects on long term anticoagulants with an INR &gt; 2.2 within 12&#xD;
               hours prior to index procedure,&#xD;
  &#xD;
            3. Significant anaemia (example: haemoglobin &lt; 8 g/dL or haematocrit &lt; 22%), within 24&#xD;
               hours prior to index procedure,&#xD;
  &#xD;
            4. Known type II heparin-induced thrombocytopenia,&#xD;
  &#xD;
            5. Documented right ventricular dysfunction &lt; 13%,&#xD;
  &#xD;
            6. Ipsilateral or contralateral lower extremity amputation,&#xD;
  &#xD;
            7. Previous groin surgery within the region of the ipsilateral vessel access,&#xD;
  &#xD;
            8. Common femoral vein diameter stenosis &gt; 50% or previous bypass surgery/stent placement&#xD;
               in the common femoral vein of target leg,&#xD;
  &#xD;
            9. Known existing nerve damage in the target leg,&#xD;
  &#xD;
           10. Nephrotic syndrome or renal insufficiency (Glomerular Filtration Rate ≤ 30 ml/min or&#xD;
               baseline serum creatinine &gt; 2.5 mg/dl) or on renal replacement therapy or albumin&#xD;
               level &lt; 3.5 g/dl or symptoms of pitting oedema,&#xD;
  &#xD;
           11. Systolic pulmonary artery pressure &gt; 60 mmHg&#xD;
  &#xD;
           12. Known allergy to any of the materials used in the PerQseal Elite device (refer to&#xD;
               Investigator's Brochure),&#xD;
  &#xD;
           13. Subject is unsuitable for surgical repair of the target leg access site,&#xD;
  &#xD;
           14. Subject has undergone a percutaneous procedure greater than 8F sheath in the target&#xD;
               vessel, within the 90-days prior to index procedure,&#xD;
  &#xD;
           15. Subject has undergone a percutaneous procedure of 8F sheath or less using an&#xD;
               absorbable intravascular closure device for haemostasis, in the target vessel, within&#xD;
               the 90-days prior to index procedure,&#xD;
  &#xD;
           16. Subject has undergone a percutaneous procedure of 8F sheath or less using a suture&#xD;
               mediated closure device or manual/mechanical pressure for haemostasis in the target&#xD;
               vessel, within the 30-days prior to index procedure,&#xD;
  &#xD;
           17. History of DVT or pulmonary embolism or venous thrombotic event,&#xD;
  &#xD;
           18. Splenectomy or suffering psoriasis or paraesthesia of the ipsilateral leg,&#xD;
  &#xD;
           19. Further planned endovascular/catheter-based procedure in the target leg in the 30-days&#xD;
               following the index procedure,&#xD;
  &#xD;
           20. Subject is enrolled in another investigational medical device or drug study,&#xD;
  &#xD;
           21. Subject has been previously enrolled in this clinical study,&#xD;
  &#xD;
           22. Subject is unable to maintain ipsilateral leg still during the index procedure&#xD;
               (restless leg syndrome),&#xD;
  &#xD;
           23. Current COVID-19 infection (with or without symptoms), recent positive test for&#xD;
               COVID-19 within two weeks, or recent exposure to a person with COVID-19 infection&#xD;
               within two weeks.&#xD;
  &#xD;
               Procedural Exclusion Criteria:&#xD;
  &#xD;
           24. Anatomically the common femoral vein is substantially posterior to the femoral artery,&#xD;
               confirmed by Duplex ultrasound,&#xD;
  &#xD;
           25. Initial common femoral venous access achieved other than with the use of an ultrasound&#xD;
               guided access approach,&#xD;
  &#xD;
           26. If the venous access is, or suspected of being, via an artery,&#xD;
  &#xD;
           27. Difficult dilation during initial target femoral vein access (e.g., that damages or&#xD;
               kinks dilators) while step-dilating up to the large-bore device,&#xD;
  &#xD;
           28. During venous puncture, the target femoral vein suspected to have experienced a&#xD;
               posterior venous wall needle puncture or underwent &gt; one needle puncture during the&#xD;
               primary procedure, with a needle larger than a micropuncture needle (&gt; 21 gauge or &gt;&#xD;
               0.819 mm diameter). (Note: not an exclusion if micropuncture technique under&#xD;
               ultrasound guidance used for femoral vein access [Ref. 30, 31]),&#xD;
  &#xD;
           29. Subject has a tissue tract (i.e., estimated distance from skin entry point to venous&#xD;
               anterior surface at venotomy) expected to be greater than 8 cm,&#xD;
  &#xD;
           30. Significant blood loss requiring transfusion of blood products during primary&#xD;
               procedure or within 30-days prior to index procedure,&#xD;
  &#xD;
           31. Activated clotting time (ACT) &gt; 250 seconds immediately prior to sheath removal or if&#xD;
               ACT measurements are expected to be &gt; 250 seconds for more than 24 hours after index&#xD;
               procedure,&#xD;
  &#xD;
           32. Target puncture site is in a vascular graft,&#xD;
  &#xD;
           33. Target venotomy greater than 26F,&#xD;
  &#xD;
           34. Target femoral vein diameter is less than 7 mm, based on Duplex ultrasound or&#xD;
               angiography,&#xD;
  &#xD;
           35. Evidence of venous diameter stenosis &gt; 20% within 15 mm proximal or distal to venotomy&#xD;
               site based on Duplex ultrasound or angiography,&#xD;
  &#xD;
           36. Target venotomy has been made in the superficial femoral vein, profunda femoris vein&#xD;
               (deep femoral vein), great saphenous vein or located less than 15 mm distal (cranial)&#xD;
               to the bifurcation of either the profunda femoris or great saphenous vein and common&#xD;
               femoral vein,&#xD;
  &#xD;
           37. Target venotomy located behind (posterior) or above (cranial) to the inguinal ligament&#xD;
               based upon bony landmarks (above femoral head on A-P projection),&#xD;
  &#xD;
           38. Subjects with an acute haematoma &gt; 4 cm diameter, arteriovenous fistula,&#xD;
               pseudoaneurysm or intraluminal thrombosis at the target access site identified&#xD;
               intra-procedurally,&#xD;
  &#xD;
           39. Evidence of bleeding around the primary procedure sheath (VARC type 1/BARC type 2 or&#xD;
               higher),&#xD;
  &#xD;
           40. Intra-procedural (angiographic or Duplex ultrasound) evidence of venous laceration,&#xD;
               dissection or stenosis within the femoral vein that would preclude use of the PerQseal&#xD;
               Elite device,&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Chris Martin</last_name>
      <phone>+353 91 395 442</phone>
      <email>Chris.Martin@vsuremed.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Venous Closure</keyword>
    <keyword>Percutaneous closure</keyword>
    <keyword>Large bore closure</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007339
  org study id: P934-00
  nct id: NCT06007339
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite
        vascular closure system when used to achieve haemostasis of common femoral venotomies created
        by 14 to 22F sheaths (venotomy up to 26F) in patients undergoing percutaneous catheter-based
        interventional procedures, with sufficient rigor to provide robust scientific evidence for
        the demonstration of clinical safety and efficacy of the PerQseal Elite closure system to
        support a CE-mark and a PMA submission.
  This study is a prospective, multicentre, single-arm study to investigate the safety and
        efficacy of the PerQseal Elite in up to 97 patients at up to 12 European investigational
        sites. The study shall not be blinded prior to, during or post the procedure. Patients
        undergoing a percutaneous catheter-based venous interventional procedure (e.g., mitral valve
        repair, leadless pacemaker implantation, circulatory assist or ECMO via large bore femoral
        vein catheter) requiring a venotomy created by 14 to 22F sheaths (venotomies up to 26F), via
        the common femoral vein will be screened against the study inclusion/exclusion criteria.
  
        All subjects shall have a 30-minute, 60-minute, pre-discharge (~48 hours), 30-Days ± 7-Days
        and 180-Days ± 30-Days follow-up assessments.
  
        All safety data from the study will be assessed by the Data Safety Monitoring Committee on a
        continuous basis.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This study is a prospective, multicentre, single-arm study to investigate the safety and efficacy of the PerQseal Elite.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Primary Safety Endpoint- Combined rate of both Major and Minor access site complications
  time frame: through 30 Days
  description: the combined rate of both Major and Minor access site complications attributable to the PerQseal Elite device§ through 30-days, as adjudicated by the Clinical Events Committee (CEC) as study device related.
  measure: Primary Effectiveness Endpoint - Time to Haemostasis
  time frame: 20 Minutes
  description: Time to Haemostasis (TTH) defined as elapsed time in minutes from PerQseal Elite (Introducer-sheath and Delivery-device) removal to first observed cessation of common femoral vein (CFV) bleeding (clinically acceptable cessation of venous bleeding), excluding cutaneous or subcutaneous oozing, and in the absence of a developing haematoma. This is assessed at the end of the index procedure prior leaving the operating room/catheterisation laboratory.
  measure: Secondary Effectiveness Endpoint - PerQseal Elite Technical Success Rate
  time frame: 10 Minutes
  description: PerQseal Elite Technical Success Rate is defined as the number of PerQseal Elite devices that are deployed and achieve haemostasis (i.e., cessation of venous bleeding excluding cutaneous or subcutaneous oozing) without need for more than 10 minutes of firm, adjunctive manual compression or alternative treatment (other than adjunctive endovascular ballooning) at target access site, divided by the total number of PerQseal Elite devices where deployment was attempted.
  measure: Secondary Effectiveness Endpoint - PerQseal Elite Treatment Success Rate
  time frame: through 30 days
  description: PerQseal Elite Treatment Success Rate is defined as the number of subjects who meet PerQseal Elite Technical Success without experiencing a device related Access Site Complication (based on CEC adjudication) through 30-days, divided by the total number of subjects where PerQseal Elite device deployment was attempted.
  measure: Secondary Effectiveness Endpoint -Time to Device Deployment (TTDD)
  time frame: 20 Minutes
  description: Time to Device Deployment is defined as the time from insertion of the PerQseal Elite delivery device into the PerQseal Elite Introducer sheath to complete removal of the PerQseal Elite (delivery device and introducer-sheath) from the subject following PerQseal Elite deployment.
  measure: Secondary Effectiveness Endpoint - Time to Ambulation
  time frame: through 24 hours
  description: Time to Ambulation is defined as: the elapsed time from PerQseal Elite removal from the subject post deployment until the subject can walk 20 feet/6 meters without venous re-bleeding at the target access site. This endpoint will be evaluated only for subjects who are ambulatory (e.g., not confined to wheelchair or bed) at the time of enrolment.
  measure: Secondary Effectiveness Endpoint - Total Closure Time
  time frame: 40 Minutes
  description: Total Closure Time is defined as: Time to Haemostasis (TTH) plus Time to Device Deployment (TTDD).
  arm group label: Investigational Device Arm (PerQseal Elite- Venous)
  arm group type: Experimental
  description: Large hole percutaneous venous closure device - PerQseal Elite
  intervention type: Device
  intervention name: PerQseal ELITE
  description: The term PerQseal Elite used singularly refers to the closure system comprising the closure device and Introducer. These individually are referred to as: "PerQseal Elite VCD" or "PerQseal Elite closure device" and/or "PerQseal Elite Introducer".
  arm group label: Investigational Device Arm (PerQseal Elite- Venous)
  other name: Percutaneous ELITE Venous Closure Device
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Chris Martin
  phone: +353 91 395 442
  email: Chris.Martin@vsuremed.com
  responsible party type: Sponsor
  sharing ipd: No