<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/NCT03234894</url>
  </required_header>
  <id_info>
    <org_study_id>G150106/A001</org_study_id>
    <nct_id>NCT03234894</nct_id>
  </id_info>
  <brief_title>Clinical Trial of the WC360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures</brief_title>
  <acronym>SiteSeal</acronym>
  <official_title>Clinical Study of the WoundCare360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wound Care 360, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wound Care 360, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Clinical Study is a pivotal study to evaluate the safety of the SiteSeal™ Adjunctive&#xD;
      Compression Device across a broad array of patients undergoing interventional endovascular&#xD;
      procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design is a single arm with 90 patients. The primary endpoints measure the risk for&#xD;
      common femoral nerve damage and common femoral artery laceration from the blind placement of&#xD;
      a Z-stitch in the soft tissue above the femoral bundle.&#xD;
&#xD;
      The sample size is 90 patients. The project objective is to demonstrate the safety of the&#xD;
      device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 2018</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>The percent of patients with common femoral nerve damage or with bleeding from femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle.</measure>
    <time_frame>24 hours</time_frame>
    <description>Femoral damage is indicated if the patient has an audible response during suture placement. Arterial laceration is visible bleeding during suture placement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-rated patient discomfort.</measure>
    <time_frame>24 hour interview</time_frame>
    <description>Patients are called back after 24 hours and asked to rate their discomfort on a 1-10 scale. The mean of all patients 1-10scale rating is reported as the discomfort of the arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percent of patients who had a major complication.</measure>
    <time_frame>30day interview</time_frame>
    <description>Major complications are defined in the protocol. Major complications are summed and the mean of the entire arm is reported as a percent of patients who had major complications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percent of patients who had a minor complication.</measure>
    <time_frame>30day interview</time_frame>
    <description>Minor complications are defined in the protocol. Minor complications are summed and the mean of the entire arm is reported as the percent of patients who had minor complications.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Bleeding</condition>
  <arm_group>
    <arm_group_label>SiteSeal Endovascular</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>After intervention (deployment and removal of the Site Seal endovascular adjunctive compression device), the physician determines whether or not there was laceration of the femoral nerve or laceration of the femoral artery per protocol. A series of possible minor and/or major complications are noted per protocol.&#xD;
There is a secondary metric as to patient reported pain on a 1-10scale.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SiteSeal Endovascular</intervention_name>
    <description>to evaluate the safety of the SiteSeal™ Endovascular Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.</description>
    <arm_group_label>SiteSeal Endovascular</arm_group_label>
    <other_name>SiteSeal Cardiovascular</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Patients between the ages 19 to 90&#xD;
&#xD;
          2. Patient or his/her legally authorized representative, has given written informed&#xD;
             consent for participation prior to the procedure&#xD;
&#xD;
          3. Procedure is an interventional procedure&#xD;
&#xD;
          4. Patient is willing to undergo all study procedures and adhere to data collection and&#xD;
             follow-up requirements&#xD;
&#xD;
          5. Patient is a candidate for elective, non-emergent cardiac or peripheral vascular&#xD;
             catheterization from the femoral artery approach&#xD;
&#xD;
          6. Patient is willing to have a pre/post procedure ultrasound.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients are &lt;19 years old&#xD;
&#xD;
          2. Patients are &gt;90years old&#xD;
&#xD;
          3. Patient has received GP IIb/IIIa inhibitors&#xD;
&#xD;
          4. Patient or patient's representative is unable to provide written informed consent.&#xD;
&#xD;
          5. Patient is unable or unwilling to adhere to data collection and follow-up requirements&#xD;
&#xD;
          6. Procedure is emergency PCI&#xD;
&#xD;
          7. Patient is on dialysis&#xD;
&#xD;
          8. Patient has a known diagnosis of fibromyalgia&#xD;
&#xD;
          9. Patients with acute coronary syndrome (i.e., unstable angina or myocardial infarction)&#xD;
             ≤ 48 hours before this catheterization procedure.&#xD;
&#xD;
         10. Patients with systolic blood pressure &lt; 90 mm Hg at the end of the catheterization&#xD;
             procedure&#xD;
&#xD;
         11. Patients who are immunocompromised&#xD;
&#xD;
         12. Patients with preexisting systemic infection or local infections at the access site&#xD;
&#xD;
         13. Patients who are known or suspected to be pregnant, or are lactating&#xD;
&#xD;
         14. Patients who have undergone prior or recent use of an intra-aortic balloon pump&#xD;
             through the arterial access site above the inguinal ligament&#xD;
&#xD;
         15. Patients who have undergone prior vascular closure device use in the ipsilateral&#xD;
             common femoral artery ≤ 30days before this catheterization procedure&#xD;
&#xD;
         16. Patients who have undergone prior use of manual or mechanical compression for closure&#xD;
             in the ipsilateral common femoral artery ≤30 days before the catheterization procedure&#xD;
&#xD;
         17. Patients requiring a repuncture at a site previously punctured within 48 hours of the&#xD;
             catheterization procedure&#xD;
&#xD;
         18. Patients who have undergone an antegrade puncture&#xD;
&#xD;
         19. Patients with puncture sites believed to be in the profunda femoris artery,&#xD;
             superficial femoral artery, or at the bifurcation of these arteries&#xD;
&#xD;
         20. Patients with puncture tract angle &gt;55°&#xD;
&#xD;
         21. Patients who are suspected to have experienced a femoral artery back wall puncture or&#xD;
             who underwent &gt; 1femoral artery puncture during the catheterization procedure&#xD;
&#xD;
         22. Patient with significant anemia (hemoglobin &lt; 10 g/dL, Hct &lt; 30%)&#xD;
&#xD;
         23. Patients with a known bleeding disorder, including thrombocytopenia (platelet count &lt;&#xD;
             100,000 cells/μL), thrombasthenia, hemophilia, or von Willebrand's disease&#xD;
&#xD;
         24. Patients with systolic blood pressure &gt;180 mm Hg or diastolic blood pressure &gt;110 mm&#xD;
             Hg at the end of this catheterization procedure, unless systolic and/or diastolic&#xD;
             pressure was lowered by pharmacological agents prior to the end of the catheterization&#xD;
             procedure&#xD;
&#xD;
         25. Patients with a baseline INR &gt;1.5 (e.g., on warfarin therapy)&#xD;
&#xD;
         26. Patients whose ACT &gt;300seconds at the end of the catheterization procedure&#xD;
&#xD;
         27. Patients who have undergone administration of low molecular weight heparin (LMWH)&#xD;
             within 8hours of this catheterization procedure&#xD;
&#xD;
         28. Patients in whom continued heparin or other anticoagulant/antiplatelet therapy is&#xD;
             planned for this patient (with the exception of glycoprotein IIb/IIIa inhibitor&#xD;
             therapy) during the first few hours following the catheterization procedure&#xD;
&#xD;
         29. Patients having a complication or complications at the femoral artery access site&#xD;
             during the catheterization procedure including bleeding, hematoma, intraluminal&#xD;
             thrombus, pseudoaneurysm, or arteriovenous fistula&#xD;
&#xD;
         30. Patients with an ipsilateral or bilateral lower extremity amputation(s)&#xD;
&#xD;
         31. Patient known to require extended hospitalization (e.g., patient is undergoing cardiac&#xD;
             surgery)&#xD;
&#xD;
         32. Patients who have a planned endovascular procedure within the next 30days after the&#xD;
             catheterization procedure&#xD;
&#xD;
         33. Patients who are currently participating in another investigational study that has not&#xD;
             concluded the follow-up period&#xD;
&#xD;
         34. Patients who have already participated in the IDE study&#xD;
&#xD;
         35. Patients who cannot adhere to or complete the study for any reason including but not&#xD;
             limited to geographical residence or life-threatening disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elias Kassab, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MOVI</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matthew Earnest, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>June 28, 2016</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>January 28, 2020</last_update_submitted>
  <last_update_submitted_qc>January 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 24, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03234894/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 12, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03234894/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 23, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03234894/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>May 26, 2020</submitted>
    <returned>June 9, 2020</returned>
    <submitted>October 14, 2020</submitted>
    <returned>November 4, 2020</returned>
    <submitted>November 13, 2020</submitted>
    <returned>December 9, 2020</returned>
  </pending_results>
  <!-- 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/NCT03234894
org study id: G150106/A001
nct id: NCT03234894
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This Clinical Study is a pivotal study to evaluate the safety of the SiteSeal™ Adjunctive
      Compression Device across a broad array of patients undergoing interventional endovascular
      procedures.
The study design is a single arm with 90 patients. The primary endpoints measure the risk for
      common femoral nerve damage and common femoral artery laceration from the blind placement of
      a Z-stitch in the soft tissue above the femoral bundle.

      The sample size is 90 patients. The project objective is to demonstrate the safety of the
      device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The percent of patients with common femoral nerve damage or with bleeding from femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle.
time frame: 24 hours
description: Femoral damage is indicated if the patient has an audible response during suture placement. Arterial laceration is visible bleeding during suture placement.
measure: Patient-rated patient discomfort.
time frame: 24 hour interview
description: Patients are called back after 24 hours and asked to rate their discomfort on a 1-10 scale. The mean of all patients 1-10scale rating is reported as the discomfort of the arm.
measure: The percent of patients who had a major complication.
time frame: 30day interview
description: Major complications are defined in the protocol. Major complications are summed and the mean of the entire arm is reported as a percent of patients who had major complications.
measure: The percent of patients who had a minor complication.
time frame: 30day interview
description: Minor complications are defined in the protocol. Minor complications are summed and the mean of the entire arm is reported as the percent of patients who had minor complications.
arm group label: SiteSeal Endovascular
arm group type: Other
description: After intervention (deployment and removal of the Site Seal endovascular adjunctive compression device), the physician determines whether or not there was laceration of the femoral nerve or laceration of the femoral artery per protocol. A series of possible minor and/or major complications are noted per protocol.
There is a secondary metric as to patient reported pain on a 1-10scale.
intervention type: Device
intervention name: SiteSeal Endovascular
description: to evaluate the safety of the SiteSeal™ Endovascular Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.
arm group label: SiteSeal Endovascular
other name: SiteSeal Cardiovascular
criteria: 
gender: All
minimum age: 19 Years
maximum age: 90 Years
healthy volunteers: No
last name: Elias Kassab, MD
role: Principal Investigator
affiliation: MOVI
last name: Matthew Earnest, MD
role: Principal Investigator
affiliation: University of Kansas Medical Center
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
provided document: 
submitted: May 26, 2020
returned: June 9, 2020
submitted: October 14, 2020
returned: November 4, 2020
submitted: November 13, 2020
returned: December 9, 2020