<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/NCT03756558</url>
  </required_header>
  <id_info>
    <org_study_id>TIS2018-01</org_study_id>
    <nct_id>NCT03756558</nct_id>
  </id_info>
  <brief_title>Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System</brief_title>
  <official_title>Cross-SealTM IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Terumo Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Terumo Medical Corporation</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>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device&#xD;
      in gaining post procedure hemostasis in subjects undergoing interventional procedures&#xD;
      requiring an 8 to 18 french size introducer sheath.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Cross-Seal device is a VCD intended for use in catheterization laboratories following&#xD;
      percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery&#xD;
      access route for large bore (8-18F ID) interventional devices. The function of Cross-Seal is&#xD;
      to percutaneously close the puncture in the artery wall (arteriotomy) through which the&#xD;
      catheters were inserted for the procedure.&#xD;
&#xD;
      The study is being conducted to demonstrate the safety and effectiveness of Cross-Seal in&#xD;
      achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous&#xD;
      transcatheter interventional procedures using a large-bore procedure sheath.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2019</start_date>
  <completion_date type="Actual">March 22, 2021</completion_date>
  <primary_completion_date type="Actual">March 22, 2021</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>Performance goal</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from Major Complications</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Freedom from major complications of the target limb. Major Complications include: access site vascular injury that requires surgical intervention, access related lower extremity ischemia, access site infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Time To Hemostasis (TTH)</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>The mean Time To Hemostasis in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from minor complications</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>The freedom from minor complications at the target limb access site. Minor Complications include: pseudoaneurysm at the access site, access site hematoma over 10cm, access site wound dehiscence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Device and procedural complications</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Adverse Events occurring in the study will be evaluated for device and/or procedural relationships to the device by the study investigator and/or Clinical Events Committee. The incidence reported will not include units, but rather be presented for each event as the occurrence rate by percentage (n/N, proportion) as applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events</measure>
    <time_frame>60 days post procedure</time_frame>
    <description>Incidence of major and minor Adverse Events (AEs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Technical Success</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Incidence of hemostasis with the investigational device without the need for any access-site-related adjunctive surgical or endovascular intervention (target limb only).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Closure Success</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Incidence of access site closure success: defined as technical success and freedom from major complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment Success</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Incidence of Treatment Success: defined as technical success and freedom from major complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of surgical or endovascular intervention post closure</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Subjects requiring adjunctive surgical or endovascular intervention to achieve hemostasis of the access site (target limb only) including type of adjunctive intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Manual Compression</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Incidence of subjects requiring adjunctive manual compression following use of the investigational device to achieve hemostasis of the access site (target limb only).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-to-Ambulation:</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Time-to-Ambulation: defined as elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Device Failure</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Incidence of device failure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Vascular Closure</condition>
  <arm_group>
    <arm_group_label>Cross-Seal System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Cross-Seal System will be used in all subjects enrolled in the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cross-Seal System</intervention_name>
    <description>Use of the Cross-Seal system to close the femoral arteriotomy</description>
    <arm_group_label>Cross-Seal System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is ≥ 18 years old&#xD;
&#xD;
          2. Subject is scheduled for elective or planned (i.e., not emergent or urgent)&#xD;
             percutaneous transcatheter interventional procedures involving access through the&#xD;
             femoral artery using 8-18 French introducer sheaths&#xD;
&#xD;
          3. Subject is able to undergo emergent vascular surgery if a complication related to the&#xD;
             vascular closure necessitates such surgery&#xD;
&#xD;
          4. Subject is willing and able to complete follow-up requirements&#xD;
&#xD;
          5. Subject, or authorized representative signs a written Informed Consent form prior&#xD;
             participating in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General Exclusion Criteria&#xD;
&#xD;
          1. Prior intra-aortic balloon pump at access site&#xD;
&#xD;
          2. Subjects with severe inflow disease (iliac artery diameter stenosis &gt; 50%) and/or&#xD;
             severe peripheral arterial disease (Rutherford Classification 5 or 6), as confirmed&#xD;
             with prior standard of care Computed Tomography Imaging, duplex ultrasound, and/or&#xD;
             intra-procedural fluoroscopy&#xD;
&#xD;
          3. Common femoral artery lumen diameter is &lt; 5 mm&#xD;
&#xD;
          4. In opinion of the investigator, significant scarring of the target access site which&#xD;
             would preclude use of the device in accordance with the IFU&#xD;
&#xD;
          5. Prior target artery closure with any closure device &lt; 90 days, or closure with manual&#xD;
             compression ≤ 30 days prior to index procedure&#xD;
&#xD;
          6. Prior vascular surgery, vascular graft, or stent in region of access site&#xD;
&#xD;
          7. Subjects receiving glycoprotein IIb/IIIa inhibitors before, during, or after the&#xD;
             catheterization procedure&#xD;
&#xD;
          8. Subjects with significant anemia&#xD;
&#xD;
          9. Subject with known bleeding disorder including thrombocytopenia (platelet count &lt;&#xD;
             100,000), thrombasthenia, hemophilia or Von Willebrand's disease&#xD;
&#xD;
         10. Subject with renal insufficiency, on dialysis therapy, or with renal transplant&#xD;
&#xD;
         11. Known severe allergy to contrast reagent that cannot be managed with premedication&#xD;
&#xD;
         12. Inability to tolerate aspirin and/or other anticoagulation/antiplatelet treatment&#xD;
&#xD;
         13. Planned anticoagulation therapy post-procedure such that the Activated Clotting Time&#xD;
             (ACT) is expected to be elevated above 350 seconds for more than 24 hours after the&#xD;
             procedure&#xD;
&#xD;
         14. Connective tissue disease (e.g., Marfan's Syndrome)&#xD;
&#xD;
         15. Thrombolytics (e.g., streptokinase, urokinase), Angiomax (bivalirudin) or other&#xD;
             thrombin-specific anticoagulants ≤ 24 hours prior to the procedure&#xD;
&#xD;
         16. Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction&#xD;
&#xD;
         17. Subjects who are morbidly obese&#xD;
&#xD;
         18. Planned major intervention or surgery, including planned endovascular procedure in the&#xD;
             target leg, within 30 days following the interventional procedure&#xD;
&#xD;
         19. Subject unable to ambulate at baseline (i.e., confined to wheelchair or bed)&#xD;
&#xD;
         20. Currently participating in a clinical study of an investigational device or drug that&#xD;
             has not completed its primary study endpoint&#xD;
&#xD;
         21. Known allergy to any device component&#xD;
&#xD;
         22. Subject is known or suspected to be pregnant or lactating&#xD;
&#xD;
         23. Evidence of active systemic or local groin infection&#xD;
&#xD;
         24. Subject has other medical, social or psychological problem that in the opinion of the&#xD;
             investigator precludes them from participating&#xD;
&#xD;
         25. Subject is mentally incompetent or a prisoner&#xD;
&#xD;
         26. New York Heart Association (NYHA) Class IV heart failure that is uncontrolled and&#xD;
             requires treatment in the Intensive Care Unit within 24 hours prior to the index&#xD;
             procedure&#xD;
&#xD;
         27. Left Ventricular Ejection Fraction (LVEF) &lt; 20%&#xD;
&#xD;
         28. Unilateral or bilateral lower extremity amputation&#xD;
&#xD;
         29. Known existing nerve damage in the target leg&#xD;
&#xD;
         30. Subjects who have already participated in this study&#xD;
&#xD;
             Intra-Procedure Exclusion Criteria&#xD;
&#xD;
         31. Access site above the most inferior border of the inferior epigastric artery (IEA)&#xD;
             and/or above the inguinal ligament based upon bony landmarks&#xD;
&#xD;
         32. Access site in the profunda femoris or superficial femoral arteries, or the&#xD;
             bifurcation of these vessels&#xD;
&#xD;
         33. Ipsilateral femoral venous sheath during the catheterization procedure&#xD;
&#xD;
         34. Common femoral artery calcium, which is visible with prior Computed Tomography Imaging&#xD;
             and/or duplex ultrasound&#xD;
&#xD;
         35. Subject in which there is difficulty inserting the introducer sheath or need for&#xD;
             greater than 2 ipsilateral arterial punctures at the start of the catheterization&#xD;
             procedure&#xD;
&#xD;
         36. Difficulty in obtaining vascular access resulting in multiple arterial punctures&#xD;
             and/or posterior arterial puncture&#xD;
&#xD;
         37. Evidence of a pre-existing hematoma (&gt; 1.5 cm in diameter), arteriovenous fistula,&#xD;
             pseudoaneurysm, or intraluminal thrombosis at the access site&#xD;
&#xD;
         38. Marked tortuosity (at the investigator's discretion) of the femoral or external iliac&#xD;
             artery in the target leg based on prior Computed Tomography imaging, fluoroscopy,&#xD;
             and/or duplex ultrasound&#xD;
&#xD;
         39. Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral&#xD;
             artery that would preclude use of the investigational device&#xD;
&#xD;
         40. Target arteriotomy &gt;18 French sheath&#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>Mazin Foteh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiothoracic and Vascular Surgeons - Austin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Prakash Krishnan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahan School of Medicine at Mt Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vascular Institute of the Rockies</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>River City Clinical Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospital</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers, The State University of New Jersey</name>
      <address>
        <city>Piscataway</city>
        <state>New Jersey</state>
        <zip>08854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mt Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Trustees of Columbia University in the City of New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Good Samaritan Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INTEGRIS Cardiovascular Physicians</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau Institute for Medical Research</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Central Heart</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holston Valley Medical Center</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiothoracic and Vascular Surgeons</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. David's Heart and Vascular dba Austin heart</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Heart Institute and Baylor St. Luke's Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Medical Group</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>October 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>October 8, 2021</last_update_submitted>
  <last_update_submitted_qc>October 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03756558
org study id: TIS2018-01
nct id: NCT03756558
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device
      in gaining post procedure hemostasis in subjects undergoing interventional procedures
      requiring an 8 to 18 french size introducer sheath.
The Cross-Seal device is a VCD intended for use in catheterization laboratories following
      percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery
      access route for large bore (8-18F ID) interventional devices. The function of Cross-Seal is
      to percutaneously close the puncture in the artery wall (arteriotomy) through which the
      catheters were inserted for the procedure.

      The study is being conducted to demonstrate the safety and effectiveness of Cross-Seal in
      achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous
      transcatheter interventional procedures using a large-bore procedure sheath.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Performance goal
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from Major Complications
time frame: 30 days post procedure
description: Freedom from major complications of the target limb. Major Complications include: access site vascular injury that requires surgical intervention, access related lower extremity ischemia, access site infection
measure: Mean Time To Hemostasis (TTH)
time frame: 30 days post procedure
description: The mean Time To Hemostasis in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device.
measure: Freedom from minor complications
time frame: 30 days post procedure
description: The freedom from minor complications at the target limb access site. Minor Complications include: pseudoaneurysm at the access site, access site hematoma over 10cm, access site wound dehiscence
measure: Incidence of Device and procedural complications
time frame: 30 days post procedure
description: Adverse Events occurring in the study will be evaluated for device and/or procedural relationships to the device by the study investigator and/or Clinical Events Committee. The incidence reported will not include units, but rather be presented for each event as the occurrence rate by percentage (n/N, proportion) as applicable.
measure: Incidence of Adverse Events
time frame: 60 days post procedure
description: Incidence of major and minor Adverse Events (AEs)
measure: Incidence of Technical Success
time frame: 30 days post procedure
description: Incidence of hemostasis with the investigational device without the need for any access-site-related adjunctive surgical or endovascular intervention (target limb only).
measure: Incidence of Closure Success
time frame: up to 30 days
description: Incidence of access site closure success: defined as technical success and freedom from major complications
measure: Incidence of Treatment Success
time frame: 30 days post procedure
description: Incidence of Treatment Success: defined as technical success and freedom from major complications
measure: Incidence of surgical or endovascular intervention post closure
time frame: 30 days post procedure
description: Subjects requiring adjunctive surgical or endovascular intervention to achieve hemostasis of the access site (target limb only) including type of adjunctive intervention.
measure: Incidence of Manual Compression
time frame: 30 days post procedure
description: Incidence of subjects requiring adjunctive manual compression following use of the investigational device to achieve hemostasis of the access site (target limb only).
measure: Time-to-Ambulation:
time frame: up to 30 days
description: Time-to-Ambulation: defined as elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding.
measure: Incidence of Device Failure
time frame: 30 days post procedure
description: Incidence of device failure
arm group label: Cross-Seal System
arm group type: Experimental
description: The Cross-Seal System will be used in all subjects enrolled in the study
intervention type: Device
intervention name: Cross-Seal System
description: Use of the Cross-Seal system to close the femoral arteriotomy
arm group label: Cross-Seal System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mazin Foteh, MD
role: Principal Investigator
affiliation: Cardiothoracic and Vascular Surgeons - Austin
last name: Prakash Krishnan
role: Principal Investigator
affiliation: Icahan School of Medicine at Mt Sinai
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country: United States
responsible party type: Sponsor
sharing ipd: No