<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/NCT03028025</url>
  </required_header>
  <id_info>
    <org_study_id>MIRB 1427</org_study_id>
    <nct_id>NCT03028025</nct_id>
  </id_info>
  <brief_title>Comparing TR Band to Statseal in Conjunction With TR Band</brief_title>
  <official_title>Radial Hemostasis is Facilitated With a Potassium Ferrate Hemostatic Patch (Statseal): the Randomized Controlled Statseal With TR Band Assessment Trial (STAT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Long Beach Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Long Beach Healthcare System</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of this study are to evaluate the performance of StatSeal Advanced&#xD;
      used in conjunction with the TR Band (SSA) as compared to the TR Band without SSA (TRB)&#xD;
      relative to: the incidence of peri-procedural radial artery occlusion (RAO) at discharge or&#xD;
      24 hours, whichever occurs first, and the Time to Hemostasis (TTH).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a physician initiated, prospective, observational, two arm, randomized study to&#xD;
      be performed at up to four experienced 'Radial First' centers (UCSD, UCLA. Arkansas Heart&#xD;
      Hospital and LBVA). A maximum of 180 patients having undergone successful radial&#xD;
      catheterization will be enrolled in the study, 60 in each arm. 60 patients will be enrolled&#xD;
      at the LBVA. Enrollment will continue at each site on discretion of the investigators until&#xD;
      each center enrolls a minimum of 30 patients, or a maximum of 180 patients are enrolled.&#xD;
      Clinicians will perform the catheterization in accordance with local standard practice, with&#xD;
      a minimum of 5,000 units of unfractionated heparin for anticoagulation. At the start of the&#xD;
      TRA procedure, prior to radial artery cannulation, a baseline Pleth-ox exam will be performed&#xD;
      for all patients and recorded on the CRF. Ulnar compression will be applied to confirm that&#xD;
      the radial artery is patent. Patients with a type D pattern exam will be excluded from the&#xD;
      study. At the conclusion of a successful transradial procedure, the patient will be&#xD;
      randomized to either SSA or TRB, each device applied per protocol &amp; IFU. It is hypothesized&#xD;
      that if radial artery compression time can be shortened to 40 minutes or less, the following&#xD;
      could result: improved catheterization lab efficiency, greater patient satisfaction and lower&#xD;
      complication rates, including RAO, may be improved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Hemostasis Using the Hemostasis Management System (HMS)</measure>
    <time_frame>within 30 min of discharge or after 24 hours</time_frame>
    <description>Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of Patients With Radial Artery Occlusion(RAO)</measure>
    <time_frame>within 30 min of discharge or after 24 hours</time_frame>
    <description>Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">184</enrollment>
  <condition>Arterial Occlusion</condition>
  <condition>Angina Pectoris</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Atherosclerosis</condition>
  <condition>Hematoma</condition>
  <condition>Anticoagulant-Induced Bleeding</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>TR Band Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TR Band: Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Statseal with TR Band</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>StatSeal: Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>StatSeal</intervention_name>
    <description>Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.</description>
    <arm_group_label>Statseal with TR Band</arm_group_label>
    <other_name>potassium ferrate disc with topical hydrophilic polymer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TR Band</intervention_name>
    <description>Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.</description>
    <arm_group_label>TR Band Only</arm_group_label>
    <other_name>Hemostasis device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient undergoing diagnostic angiography or PCI via the radial artery&#xD;
&#xD;
          -  Patients with a Barbeau test prior to the procedure showing pattern A,B,or&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of a radial sheath larger than 6 Fr (a 7Fr-in-6 Glidesheath Slender ® is allowed).&#xD;
&#xD;
          -  Use of an anticoagulant other than unfractionated heparin or bivalirudin.&#xD;
&#xD;
          -  Any anticipated need for continued anticoagulation post-catheterization. Glycoprotein&#xD;
             inhibitors are acceptable.&#xD;
&#xD;
          -  Any active treatment with oral anticoagulants continued during course of procedure.&#xD;
&#xD;
          -  Presence of arteriovenous dialysis fistula in the ipsilateral arm.&#xD;
&#xD;
          -  Any physical deformity or trauma / injury of either wrist that would prevent proper&#xD;
             placement or function of the hemostasis band.&#xD;
&#xD;
          -  Raynaud's syndrome or known peripheral vascular disease of the forearm.&#xD;
&#xD;
          -  Mental incompetence or inability to follow the instructions to complete the study.&#xD;
&#xD;
          -  History or presence of Radial Artery Occlusion.&#xD;
&#xD;
          -  Barbeau test showing Pattern D.&#xD;
&#xD;
          -  Patients undergoing catheterization from the femoral or ulnar artery approach.&#xD;
&#xD;
          -  Cardiogenic shock or any clinical instability as assessed by the physician performing&#xD;
             the procedure.&#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>Arnold H Seto, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Long Beach Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Veteran Affairs Long Beach</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://eurointervention.pcronline.com/article/radial-haemostasis-is-facilitated-with-a-potassium-ferrate-haemostatic-patch-the-statseal-with-tr-band-assessment-trial-stat</url>
    <description>HTML link to document</description>
  </link>
  <results_reference>
    <citation>Seto AH, Rollefson W, Patel MP, Suh WM, Tehrani DM, Nguyen JA, Amador DG, Behnamfar O, Garg V, Cohen MG. Radial haemostasis is facilitated with a potassium ferrate haemostatic patch: the Statseal with TR Band assessment trial (STAT). EuroIntervention. 2018 Dec 7;14(11):e1236-e1242. doi: 10.4244/EIJ-D-18-00101.</citation>
    <PMID>29769165</PMID>
  </results_reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>November 17, 2017</results_first_submitted>
  <results_first_submitted_qc>February 10, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 12, 2018</results_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VA Long Beach Healthcare System</investigator_affiliation>
    <investigator_full_name>Arnold Seto</investigator_full_name>
    <investigator_title>Chief of Cardiology</investigator_title>
  </responsible_party>
  <keyword>radial artery occlusion</keyword>
  <keyword>time to hemostasis</keyword>
  <keyword>radial artery</keyword>
  <keyword>transradial catheterization</keyword>
  <keyword>TR band</keyword>
  <keyword>Statseal</keyword>
  <keyword>hemostasis band</keyword>
  <keyword>potassium ferrate</keyword>
  <keyword>percutaneous coronary intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Arterial Occlusive Diseases</mesh_term>
    <mesh_term>Hematoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatics</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <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>September 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03028025/Prot_000.pdf</document_url>
    </provided_document>
    <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 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03028025/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>TR Band Only</title>
          <description>Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.</description>
        </group>
        <group group_id="P2">
          <title>Statseal With TR Band</title>
          <description>Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="94"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TR Band Only</title>
          <description>TR Band: Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.</description>
        </group>
        <group group_id="B2">
          <title>Statseal With TR Band</title>
          <description>StatSeal: Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="87"/>
            <count group_id="B2" value="93"/>
            <count group_id="B3" value="180"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="93"/>
                    <count group_id="B3" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="93"/>
                    <count group_id="B3" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.5" spread="9.8"/>
                    <measurement group_id="B2" value="65.8" spread="11.8"/>
                    <measurement group_id="B3" value="66.15" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="93"/>
                    <count group_id="B3" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="93"/>
                    <count group_id="B3" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Barbeau Class A</title>
          <description>A Barbeau test is performed to evaluate the patency of the radiopalmar arch. This is performed by compressing the radial artery for up to 2 minutes and observing the resulting waveform changes. The procedure can be performed in patients with Barbeau classification waveform A, B, or C. All patients received baseline assessment of the hand circulation using the Barbeau's test on a scale A-D, A being patent radial artery. Patients who exhibit a type D waveform indicates an incomplete palmar arch.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="93"/>
                    <count group_id="B3" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Hemostasis Using the Hemostasis Management System (HMS)</title>
        <description>Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes.</description>
        <time_frame>within 30 min of discharge or after 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TR Band Only</title>
            <description>Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.</description>
          </group>
          <group group_id="O2">
            <title>Statseal With TR Band</title>
            <description>Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Hemostasis Using the Hemostasis Management System (HMS)</title>
          <description>Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160" spread="42.75"/>
                    <measurement group_id="O2" value="42.95" spread="13.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Patients With Radial Artery Occlusion(RAO)</title>
        <description>Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.</description>
        <time_frame>within 30 min of discharge or after 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TR Band Only</title>
            <description>Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.</description>
          </group>
          <group group_id="O2">
            <title>Statseal With TR Band</title>
            <description>Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Patients With Radial Artery Occlusion(RAO)</title>
          <description>Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All participants in both groups were monitored post-cardiac catheterization until discharge. Discharge time varied per participant. Outpatient discharge time ranged from two to four hours (unless admitted as inpatient post-procedure). Inpatients were monitored until radial artery patency was observed post-procedure, and were observed for one to two days.</time_frame>
      <desc>All participants were monitored for radial artery occlusion as well as hematoma formation, and were reported if observed.</desc>
      <group_list>
        <group group_id="E1">
          <title>TR Band Only</title>
          <description>TR Band: Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.</description>
        </group>
        <group group_id="E2">
          <title>Statseal With TR Band</title>
          <description>StatSeal: Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Radial Artery Occlusion</sub_title>
                <description>Radial artery occlusion occurred in 2% of patients in the PFHP group, compared to none in the TRB group.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <description>Hematomas in two TRB and three PFHP patients occurred proximal to the TRB early during compression, indicating potentially inaccurate placement of the TR band over the arteriotomy or wire perforation of a small branch during initial access.</description>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was not adequately powered for RAO/hematomas, and was open-label so could not be blinded. Our primary endpoint of time to TRB deflation was subject to differential treatment.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Arnold Seto</name_or_title>
      <organization>VALBHS</organization>
      <phone>562-826-8000</phone>
      <email>arnold.seto@va.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03028025
org study id: MIRB 1427
nct id: NCT03028025
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
The primary objectives of this study are to evaluate the performance of StatSeal Advanced
      used in conjunction with the TR Band (SSA) as compared to the TR Band without SSA (TRB)
      relative to: the incidence of peri-procedural radial artery occlusion (RAO) at discharge or
      24 hours, whichever occurs first, and the Time to Hemostasis (TTH).
This study is a physician initiated, prospective, observational, two arm, randomized study to
      be performed at up to four experienced 'Radial First' centers (UCSD, UCLA. Arkansas Heart
      Hospital and LBVA). A maximum of 180 patients having undergone successful radial
      catheterization will be enrolled in the study, 60 in each arm. 60 patients will be enrolled
      at the LBVA. Enrollment will continue at each site on discretion of the investigators until
      each center enrolls a minimum of 30 patients, or a maximum of 180 patients are enrolled.
      Clinicians will perform the catheterization in accordance with local standard practice, with
      a minimum of 5,000 units of unfractionated heparin for anticoagulation. At the start of the
      TRA procedure, prior to radial artery cannulation, a baseline Pleth-ox exam will be performed
      for all patients and recorded on the CRF. Ulnar compression will be applied to confirm that
      the radial artery is patent. Patients with a type D pattern exam will be excluded from the
      study. At the conclusion of a successful transradial procedure, the patient will be
      randomized to either SSA or TRB, each device applied per protocol & IFU. It is hypothesized
      that if radial artery compression time can be shortened to 40 minutes or less, the following
      could result: improved catheterization lab efficiency, greater patient satisfaction and lower
      complication rates, including RAO, may be improved.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Time to Hemostasis Using the Hemostasis Management System (HMS)
time frame: within 30 min of discharge or after 24 hours
description: Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes.
measure: Percent of Patients With Radial Artery Occlusion(RAO)
time frame: within 30 min of discharge or after 24 hours
description: Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.
arm group label: TR Band Only
arm group type: Active Comparator
description: TR Band: Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.
arm group label: Statseal with TR Band
arm group type: Experimental
description: StatSeal: Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.
intervention type: Device
intervention name: StatSeal
description: Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.
arm group label: Statseal with TR Band
other name: potassium ferrate disc with topical hydrophilic polymer
intervention type: Device
intervention name: TR Band
description: Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.
arm group label: TR Band Only
other name: Hemostasis device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arnold H Seto, M.D.
role: Principal Investigator
affiliation: VA Long Beach Hospital
facility: 
country: United States
url: https://eurointervention.pcronline.com/article/radial-haemostasis-is-facilitated-with-a-potassium-ferrate-haemostatic-patch-the-statseal-with-tr-band-assessment-trial-stat
description: HTML link to document
citation: Seto AH, Rollefson W, Patel MP, Suh WM, Tehrani DM, Nguyen JA, Amador DG, Behnamfar O, Garg V, Cohen MG. Radial haemostasis is facilitated with a potassium ferrate haemostatic patch: the Statseal with TR Band assessment trial (STAT). EuroIntervention. 2018 Dec 7;14(11):e1236-e1242. doi: 10.4244/EIJ-D-18-00101.
PMID: 29769165
responsible party type: Principal Investigator
investigator affiliation: VA Long Beach Healthcare System
investigator full name: Arnold Seto
investigator title: Chief of Cardiology
mesh term: Cardiovascular Diseases
mesh term: Coronary Artery Disease
mesh term: Atherosclerosis
mesh term: Angina Pectoris
mesh term: Arterial Occlusive Diseases
mesh term: Hematoma
mesh term: Hemostatics
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was not adequately powered for RAO/hematomas, and was open-label so could not be blinded. Our primary endpoint of time to TRB deflation was subject to differential treatment.
point of contact: 