<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/NCT01722877</url>
  </required_header>
  <id_info>
    <org_study_id>JS-ISR-001, version 1, Rev 2</org_study_id>
    <nct_id>NCT01722877</nct_id>
  </id_info>
  <brief_title>JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions</brief_title>
  <acronym>JetStreamISR</acronym>
  <official_title>Safety and Effectiveness of JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions: A Prospective Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Midwest Cardiovascular Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MEDRAD, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Midwest Cardiovascular Research Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads&#xD;
      to improved overall results compared to balloon angioplasty alone. However, scar tissue&#xD;
      development can occur within the stent, a process called restenosis. Treatment of these&#xD;
      in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue&#xD;
      is frequently seen. Several methods have been proposed to treat in-stent restenosis in the&#xD;
      lower leg arteries but mixed results have been noted. In this study we hypothesize that&#xD;
      simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can&#xD;
      lead to a high rate of acute procedural success with low intraprocedural complications and an&#xD;
      acceptable recurrence rate of restenosis at 6-month follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data not available yet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Acute Procedural Success</measure>
    <time_frame>intraprocedural</time_frame>
    <description>Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patency</measure>
    <time_frame>6 months</time_frame>
    <description>Patency is defined as Peak Systolic Velocity Ratio (PSVR) of &lt; 2.4 by duplex criteria. PSVR is obtained by dividing velocity (cm/sec) at the lesion site to the velocity immediately proximal to the lesion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Revascularization</measure>
    <time_frame>6 months</time_frame>
    <description>Reintervention on the same index lesion at 6 months</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Acute Device Success</measure>
    <time_frame>intraprocedural</time_frame>
    <description>Acute device success is defined as less than or equal to 50% residual stenosis at the index lesion using the JetStream device alone and with no adjunctive balloon angioplasty therapy (via Quantitative Vascular Analysis) and with no serious adverse events.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Restenosis</condition>
  <condition>Peripheral Vascular Disease</condition>
  <arm_group>
    <arm_group_label>JetStream Atherectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>JetStream Navitus</intervention_name>
    <description>Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.</description>
    <arm_group_label>JetStream Atherectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is 18 years of age or older.&#xD;
&#xD;
          2. Subject presents with clinical evidence of peripheral arterial disease with ISR in the&#xD;
             femoropopliteal segment (includes common femoral, superficial femoral and popliteal)&#xD;
&#xD;
          3. Subject presents with a Rutherford Classification of 1-5 and has symptoms of rest limb&#xD;
             pain, ulcerations or claudication.&#xD;
&#xD;
          4. Target lesion(s) must be viewed angiographically and have ≥50% stenosis.&#xD;
&#xD;
          5. The atherectomy wire must be placed entirely across all lesions to be treated with no&#xD;
             visible evidence of clear or suspected subintimal/substent wire passage.&#xD;
&#xD;
          6. The main target vessel reference diameter must be at least 5 mm.&#xD;
&#xD;
          7. One patent distal run-off vessel with brisk flow is required.&#xD;
&#xD;
          8. Patient is an acceptable candidate for percutaneous intervention using the Jetstream&#xD;
             NAVITUS System in accordance with its labeled instructions for use.&#xD;
&#xD;
          9. Patient has signed approved informed consent.&#xD;
&#xD;
         10. Patient is willing to comply with the follow-up evaluations at specified times.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is unable to understand the study or has a history of non-compliance with&#xD;
             medical advice.&#xD;
&#xD;
          2. Subject is unwilling or unable to sign the Informed Consent Form (ICF).&#xD;
&#xD;
          3. Subject is currently enrolled in another clinical investigational study that might&#xD;
             clinically interfere with the current study endpoints (e.g., limit use of&#xD;
             study-recommended medications, etc.).&#xD;
&#xD;
          4. Subject is pregnant or planning to become pregnant within the study period.&#xD;
&#xD;
          5. Subject has a known sensitivity to contrast media and the sensitivity cannot be&#xD;
             adequately pre-medicated for.&#xD;
&#xD;
          6. Subject is diagnosed with chronic renal failure or has a creatinine level &gt; 2.5 mg/dl&#xD;
             and is not on chronic dialysis.&#xD;
&#xD;
          7. Subject has a known allergy to heparin, ASA, Plavix.&#xD;
&#xD;
          8. Subject has a history of bleeding disorders or platelet count &lt; 80,000 cells/ml.&#xD;
&#xD;
          9. Subject experiences ongoing cardiac problems (e.g., cardiac arrhythmias, congestive&#xD;
             heart failure exacerbation, myocardial infarction, etc.) that, per the investigator,&#xD;
             would not make the subject an ideal candidate for study procedures.&#xD;
&#xD;
         10. Subject has a CVA or TIA within 4 weeks prior to JetStream procedure.&#xD;
&#xD;
         11. Subject has an anticipated life span of less than 6 months.&#xD;
&#xD;
         12. Subject is suspected of having an active systemic infection.&#xD;
&#xD;
         13. Subject per the investigator's medical judgment must be excluded from the study.&#xD;
&#xD;
         14. Limited vascular access that precludes safe advancement of the Jetstream NAVITUS&#xD;
             System to the target lesion(s).&#xD;
&#xD;
         15. Patient has evidence of intracranial or gastrointestinal bleeding within the past 3&#xD;
             months.&#xD;
&#xD;
         16. Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal&#xD;
             organ within the past 14 days.&#xD;
&#xD;
         17. Patient has any planned surgical intervention or endovascular procedure within 15 days&#xD;
             after the index procedure.&#xD;
&#xD;
         18. Use of another debulking device during the index procedure prior to the Jetstream&#xD;
             NAVITUS System.&#xD;
&#xD;
         19. Use of another debulking device after the Jetstream NAVITUS system.&#xD;
&#xD;
             -&#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>Nicolas W Shammas, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Midwest Cardiovascular Research Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Trinity Bettendorf Medical Center</name>
      <address>
        <city>Bettendorf</city>
        <state>Iowa</state>
        <zip>52722</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <results_first_submitted>March 25, 2017</results_first_submitted>
  <results_first_submitted_qc>March 25, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 5, 2017</results_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Restenosis</keyword>
  <keyword>aspiration</keyword>
  <keyword>in-stent restenosis</keyword>
  <keyword>atherectomy</keyword>
  <keyword>superficial femoral artery</keyword>
  <keyword>popliteal artery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Manuscript will be published in JEVT early 2016</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>29 patients with FP ISR in 32 limbs were treated at 2 medical centers by 2 operators from October 2012 to August 2014. Patients were eligible only if they had a more or equal 50% in-stent restenotic lesion in the superficial femoral or popliteal arteries (estimated diameter ≥5 mm), Rutherford category 1-5, and at least one patent runoff vessel.</recruitment_details>
      <pre_assignment_details>Patients were excluded if they were not able to give informed consent, had a creatinine level &gt;2.5 mg/dL, were unable to take antiplatelet drugs, or had a planned surgical or endovascular procedure within 15 days of the index procedure. After consenting, patient were excluded if had denovo disease or no in-stent restenosis in the target vessel.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>JetStream Atherectomy</title>
          <description>Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>JetStream Atherectomy</title>
          <description>Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery. Patients were eligible for the study only if they had a more or equal 50% in-stent restenotic lesion in the superficial femoral or popliteal arteries (estimated diameter ≥5 mm), Rutherford category 1-5 ischemia, and at least one patent infrapopliteal runoff vessel. Patients were excluded if they were not able to give informed consent, had a creatinine level &gt;2.5 mg/dL, were unable to take antiplatelet drugs, or had a planned surgical or endovascular procedure within 15 days of the index procedure.The JetStream was used as a first modality of treatment, no other debulking devices, cutting/scoring balloons, or cryogenic balloons were allowed.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="29"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.9" spread="11.7"/>
                  </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="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </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_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Acute Procedural Success</title>
        <description>Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.</description>
        <time_frame>intraprocedural</time_frame>
        <group_list>
          <group group_id="O1">
            <title>JetStream Atherectomy</title>
            <description>Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature.&#xD;
JetStream Navitus: Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Procedural Success</title>
          <description>Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.</description>
          <units>limbs</units>
          <param>Count of Units</param>
          <units_analyzed>limbs</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>limbs</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patency</title>
        <description>Patency is defined as Peak Systolic Velocity Ratio (PSVR) of &lt; 2.4 by duplex criteria. PSVR is obtained by dividing velocity (cm/sec) at the lesion site to the velocity immediately proximal to the lesion.</description>
        <time_frame>6 months</time_frame>
        <population>Only 25 limbs had duplex ultrasound at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>JetStream Atherectomy</title>
            <description>Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.&#xD;
25 patients in the Jetstream ISR study had a duplex Ultrasound to evaluate for patency of treated vessel at 6 months. Remaining patients did not have a DUS.</description>
          </group>
        </group_list>
        <measure>
          <title>Patency</title>
          <description>Patency is defined as Peak Systolic Velocity Ratio (PSVR) of &lt; 2.4 by duplex criteria. PSVR is obtained by dividing velocity (cm/sec) at the lesion site to the velocity immediately proximal to the lesion.</description>
          <population>Only 25 limbs had duplex ultrasound at 6 months.</population>
          <units>Percentage of patent limbs</units>
          <param>Number</param>
          <units_analyzed>limbs</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>limbs</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Revascularization</title>
        <description>Reintervention on the same index lesion at 6 months</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>JetStream Atherectomy</title>
            <description>Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.</description>
          </group>
        </group_list>
        <measure>
          <title>Target Lesion Revascularization</title>
          <description>Reintervention on the same index lesion at 6 months</description>
          <units>lesions</units>
          <param>Count of Units</param>
          <units_analyzed>lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Acute Device Success</title>
        <description>Acute device success is defined as less than or equal to 50% residual stenosis at the index lesion using the JetStream device alone and with no adjunctive balloon angioplasty therapy (via Quantitative Vascular Analysis) and with no serious adverse events.</description>
        <time_frame>intraprocedural</time_frame>
        <group_list>
          <group group_id="O1">
            <title>JetStream Atherectomy</title>
            <description>Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Device Success</title>
          <description>Acute device success is defined as less than or equal to 50% residual stenosis at the index lesion using the JetStream device alone and with no adjunctive balloon angioplasty therapy (via Quantitative Vascular Analysis) and with no serious adverse events.</description>
          <units>limbs</units>
          <param>Count of Units</param>
          <units_analyzed>limbs</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>limbs</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <desc>Death</desc>
      <group_list>
        <group group_id="E1">
          <title>JetStream Atherectomy</title>
          <description>Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Target lesion revascularization</sub_title>
                <description>retreatment of the same lesion at 6 month</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="29"/>
              </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="3" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COPD exacerbation</sub_title>
                <description>worsening chronic obstructive pulmonary disease symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>non target vessel revascularization</sub_title>
                <description>treatment of a non target vessel</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
              </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>This is a feasibility study that will need to be validated with larger multicenter trials.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr Nicolas W Shammas</name_or_title>
      <organization>Midwest Cardiovascular Research Foundation</organization>
      <phone>5633200263</phone>
      <email>shammas@mchsi.com</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/NCT01722877
org study id: JS-ISR-001, version 1, Rev 2
nct id: NCT01722877
lead sponsor: 
collaborator: 
has dmc: No
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads
      to improved overall results compared to balloon angioplasty alone. However, scar tissue
      development can occur within the stent, a process called restenosis. Treatment of these
      in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue
      is frequently seen. Several methods have been proposed to treat in-stent restenosis in the
      lower leg arteries but mixed results have been noted. In this study we hypothesize that
      simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can
      lead to a high rate of acute procedural success with low intraprocedural complications and an
      acceptable recurrence rate of restenosis at 6-month follow-up.
Data not available yet.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acute Procedural Success
time frame: intraprocedural
description: Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.
measure: Patency
time frame: 6 months
description: Patency is defined as Peak Systolic Velocity Ratio (PSVR) of < 2.4 by duplex criteria. PSVR is obtained by dividing velocity (cm/sec) at the lesion site to the velocity immediately proximal to the lesion.
measure: Target Lesion Revascularization
time frame: 6 months
description: Reintervention on the same index lesion at 6 months
measure: Acute Device Success
time frame: intraprocedural
description: Acute device success is defined as less than or equal to 50% residual stenosis at the index lesion using the JetStream device alone and with no adjunctive balloon angioplasty therapy (via Quantitative Vascular Analysis) and with no serious adverse events.
arm group label: JetStream Atherectomy
arm group type: Experimental
description: Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature.
intervention type: Device
intervention name: JetStream Navitus
description: Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.
arm group label: JetStream Atherectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicolas W Shammas, MD, MS
role: Principal Investigator
affiliation: Midwest Cardiovascular Research Foundation
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vascular Diseases
mesh term: Peripheral Vascular Diseases
mesh term: Peripheral Arterial Disease
sharing ipd: Yes
ipd description: Manuscript will be published in JEVT early 2016
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This is a feasibility study that will need to be validated with larger multicenter trials.
point of contact: 