<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/NCT03268018</url>
  </required_header>
  <id_info>
    <org_study_id>D034698</org_study_id>
    <nct_id>NCT03268018</nct_id>
  </id_info>
  <brief_title>ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study</brief_title>
  <acronym>MODIFY</acronym>
  <official_title>ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spectranetics Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spectranetics Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes&#xD;
      using a new calcium atherectomy and modification solution in patients with balloon resistant&#xD;
      calcified lesions in infrainguinal disease. The intent is to both debulk and modify the&#xD;
      vessel to restore blood flow, improve vessel compliance and drive better outcomes. The MODIFY&#xD;
      Pilot study will evaluate safety and performance measurements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 7, 2017</start_date>
  <completion_date type="Actual">March 18, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2017</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>Primary performance defined as minimum lumen diameter measured pre-laser atherectomy and post-calcium modification as well as the ability to dilate a previously balloon resistant lesion after calcium modification procedure</measure>
    <time_frame>Index procedure</time_frame>
    <description>Minimum Lumen Diameter (MLD) measured pre-laser atherectomy and post-calcium modification, as measured by angiography and QVA.&#xD;
The ability to dilate a previously balloon resistant lesion after calcium modification procedure with low pressure balloon inflation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary safety as defined as major adverse event (MAE) composite of all cause death, target vessel revascularization and major amputation of the target limb.</measure>
    <time_frame>30 days</time_frame>
    <description>Safety outcome through 30-day follow-up (MAE composite):&#xD;
All cause death Target vessel revascularization (TVR) Major amputation of target limb</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Single arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser induced pressure wave calcium modification</intervention_name>
    <description>A calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes</description>
    <arm_group_label>Single arm</arm_group_label>
    <other_name>Laser atherectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient age ≥ 18 years&#xD;
&#xD;
          2. Patient agrees to participate and comply with the protocol by signing an Ethics&#xD;
             Committee approved consent form&#xD;
&#xD;
          3. Peripheral arterial disease with a documented Rutherford Class 2-5 and&#xD;
&#xD;
               1. a resting ankle-brachial index (ABI) of &lt;0.9 or an abnormal exercise ABI (&lt;0.75)&#xD;
                  if resting ABI is normal. Patient with incompressible arteries (ABI &gt;1.2) must&#xD;
                  have a toe brachial index (TBI) &lt;0.7 in target limb;&#xD;
&#xD;
               2. or a previous intervention to the target vessels with reoccurrence of symptoms&#xD;
&#xD;
          4. Balloon resistant calcific lesion apparent on angiogram by inability to dilate lesion&#xD;
             to less than 50% diameter stenosis (DS)&#xD;
&#xD;
          5. Lesion to include fluoroscopic evidence of calcification: 1) on parallel sides of the&#xD;
             vessel and 2) extending greater than 1 cm in length&#xD;
&#xD;
          6. De novo or restenotic lesion of the SFA, popliteal or infrapopliteal artery&#xD;
&#xD;
          7. Minimum reference vessel diameter (RVD) of 2.5mm&#xD;
&#xD;
          8. Minimum target lesion length of ≥ 5cm&#xD;
&#xD;
          9. At least one patent (&lt;50% stenosed) runoff vessel to the foot&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is pregnant or breast feeding (Female subjects of childbearing potential must&#xD;
             have negative serum pregnancy test 7 days prior to treatment)&#xD;
&#xD;
          2. Life expectancy &lt; 12 months&#xD;
&#xD;
          3. Cerebrovascular accident &lt; 60 days prior to procedure&#xD;
&#xD;
          4. Myocardial infarction &lt; 60 days prior to procedure&#xD;
&#xD;
          5. Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for&#xD;
             procedure/follow up&#xD;
&#xD;
          6. Known allergy to contrast media that cannot adequately be pre-medicated prior to study&#xD;
             procedure&#xD;
&#xD;
          7. Uncontrolled hypercoagulability or history of HIT or HITT syndrome&#xD;
&#xD;
          8. Serum creatinine ≥ 2.5 mg/dL tested within a week prior to procedure&#xD;
&#xD;
          9. Patient is simultaneously participating in another investigational drug or device&#xD;
             study that will interfere with the 30 day Safety Endpoint&#xD;
&#xD;
         10. Patient is not eligible for bypass surgery or endovascular intervention&#xD;
&#xD;
         11. Planned major amputation&#xD;
&#xD;
         12. Planned or predicted cardiovascular surgical or interventional procedures prior to&#xD;
             completion of the 30-day follow-up (including, but not limited to aortic, renal,&#xD;
             cardiac, carotid, contralateral femoropopliteal, and contralateral below the knee&#xD;
&#xD;
         13. Lesion located within a stent or endograft&#xD;
&#xD;
         14. Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis ≥ 50% DS&#xD;
             that is not successfully treated prior to index procedure&#xD;
&#xD;
         15. Target lesion could not be crossed with the guidewire or support catheter&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Onze Lieve Vrouw Ziekenhuis</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint Blasius</name>
      <address>
        <city>Dendermonde</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>calcium</keyword>
  <keyword>peripheral arterial disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <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/NCT03268018
org study id: D034698
nct id: NCT03268018
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes
      using a new calcium atherectomy and modification solution in patients with balloon resistant
      calcified lesions in infrainguinal disease. The intent is to both debulk and modify the
      vessel to restore blood flow, improve vessel compliance and drive better outcomes. The MODIFY
      Pilot study will evaluate safety and performance measurements.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary performance defined as minimum lumen diameter measured pre-laser atherectomy and post-calcium modification as well as the ability to dilate a previously balloon resistant lesion after calcium modification procedure
time frame: Index procedure
description: Minimum Lumen Diameter (MLD) measured pre-laser atherectomy and post-calcium modification, as measured by angiography and QVA.
The ability to dilate a previously balloon resistant lesion after calcium modification procedure with low pressure balloon inflation.
measure: Primary safety as defined as major adverse event (MAE) composite of all cause death, target vessel revascularization and major amputation of the target limb.
time frame: 30 days
description: Safety outcome through 30-day follow-up (MAE composite):
All cause death Target vessel revascularization (TVR) Major amputation of target limb
arm group label: Single arm
arm group type: Other
intervention type: Device
intervention name: Laser induced pressure wave calcium modification
description: A calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes
arm group label: Single arm
other name: Laser atherectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Calcium
sharing ipd: No