<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/NCT03807531</url>
  </required_header>
  <id_info>
    <org_study_id>CP-002</org_study_id>
    <nct_id>NCT03807531</nct_id>
  </id_info>
  <brief_title>A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee</brief_title>
  <acronym>DEEPER OUS</acronym>
  <official_title>A Non-randomized Trial of the Temporary Spur Stent System for the Treatment of Lesions Located in the Infrapopliteal Arteries Outside of the United States</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ReFlow Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ClinLogix. LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>ReFlow Medical, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to evaluate the performance and safety of the Temporary Spur&#xD;
      Stent System (TSS). The TSS is intended for use in conjunction with a commercially available&#xD;
      drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic&#xD;
      lesions.&#xD;
&#xD;
      This study is a prospective, non-randomized, multicenter, single arm trial, with sites in New&#xD;
      Zealand, Germany, and Switzerland.&#xD;
&#xD;
      At least two and no more than 10 sites are expected to participate, with 100 subjects&#xD;
      enrolled (no more than 40 at a single site).&#xD;
&#xD;
      The study follow up will take place over a period of 365 days. A vessel recoil substudy will&#xD;
      be included for a select group of subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this clinical study is to evaluate the performance and safety of the Temporary&#xD;
      Spur Stent System (TSS) for subjects with infrapopliteal arterial disease.&#xD;
&#xD;
      The Temporary Spur Stent System is intended for use in conjunction with a commercially&#xD;
      available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or&#xD;
      restenotic lesions.&#xD;
&#xD;
      The TSS has been developed to provide another treatment option for patients with Peripheral&#xD;
      Arterial Disease (PAD), and Critical Limb Ischemia (CLI).&#xD;
&#xD;
      Up to 100 subjects will be treated with the Temporary Spur Stent System in conjunction with&#xD;
      an approved Drug Coated Balloon (DCB). No less than 1 subject and no more than 40 subjects&#xD;
      will be enrolled at a single site.&#xD;
&#xD;
      A vessel recoil substudy is included in the trial. The purpose of this study is to evaluate&#xD;
      vessel recoil in a select group of subjects (no more than 10 per site, up to 35 subjects in&#xD;
      total). This will be conducted by obtaining measurements using Optical Coherence Tomography&#xD;
      (OCT), Intravascular Ultrasound (IVUS), or Quantitative Vascular Analysis (QVA) of the target&#xD;
      vessel during the index procedure.&#xD;
&#xD;
      The statistical analysis for this trial will use as a comparator a performance goal derived&#xD;
      from a meta-analysis of infrapopliteal balloon angioplasty. Descriptive statistics may be&#xD;
      used to describe other data points.&#xD;
&#xD;
      Subjects will be asked to participate in a baseline evaluation visit, the index procedure, a&#xD;
      30 day follow up visit, a 90 day follow up visit, a 180 day follow up visit, and a 365 day&#xD;
      follow up visit. The baseline evaluation and index procedure visits may be combined. At each&#xD;
      follow up visit, the subject will undergo a physical exam with wound evaluation (if&#xD;
      applicable) including pictures, a medication history and compliance review, Ankle Brachial&#xD;
      and Toe Brachial Indices (ABI and TBI), a duplex ultrasound of the treated limb, review of&#xD;
      symptoms, and Adverse Events (AE) assessment. Subjects may choose to withdraw from the study&#xD;
      at any time, for any reason. If subjects choose to withdraw, they will be asked to undergo an&#xD;
      unscheduled study visit consisting of the aforementioned procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 11, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</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>Multicenter, non-randomized, single-arm study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization)</measure>
    <time_frame>6 months</time_frame>
    <description>The primary performance endpoint will be primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Freedom from device and procedure-related death through 30 days post-procedure</measure>
    <time_frame>30 days</time_frame>
    <description>The primary safety endpoint is freedom from device and procedure-related death through 30 days post-procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from clinically driven target lesion revascularization through 6 months post procedure.</measure>
    <time_frame>6 months</time_frame>
    <description>The secondary efficacy endpoint is freedom from clinically driven target lesion revascularization through 6 months post procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in Rutherford class score at 3, 6 and 12 months.</measure>
    <time_frame>3, 6, and 12 months</time_frame>
    <description>The second secondary efficacy measurement is decrease in Rutherford class score at 3, 6 and 12 months. Rutherford score is a classification system for patients with peripheral vascular disease.&#xD;
Categories are numbered from 0 to 6, with 0 being asymptomatic, and 6 being major tissue loss, functional foot no longer salvageable. Higher values are therefore considered a worse outcome.&#xD;
Rutherford class zero: No symptoms; Rutherford class 1: Mild Claudication (minimal leg pain with ambulation) symptoms; Rutherford Class 2: Moderate Claudication (moderate leg pain with ambulation); Rutherford Class 3: Severe claudication (severe leg pain with ambulation); Rutherford Class 4: Ischemic Rest pain (leg pain at rest); Rutherford Class 5: Minor tissue loss (nonhealing ulcer, focal gangrene, diffuse pedal ischemia); Rutherford class 6: Major tissue loss (extending above the transmetatarsal TM level, functional foot no longer salvageable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound healing for subjects with Rutherford class 5 at 6 and 12 months, as assessed by the investigator using WIfI score and descriptive characteristics, including change in wound size measured by any decrease in wound surface area.</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>The third secondary efficacy endpoint is wound healing for subjects with Rutherford class 5 at 6 and 12 months, as assessed by the investigator using WIfI score and descriptive characteristics, including change in wound size measured by any decrease in wound surface area.&#xD;
The WIfI classification scoring system is a grading system using a composite score of wound (W), ischemia (I), and foot infection (fi). These three different categories are graded from 0 to 3 with 0 being the best and 3 being the worst.&#xD;
The total score will be provided (clinical stage 1-5), which is used to estimate the risk for major amputation at one year. Patients with a score of 1 are considered low risk, and patients with a score of 5 are considered high risk (foot not salvageable). Therefore, higher values are considered a worse outcome.&#xD;
The composite score is calculated by adding up the score from each category.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Treatment with TSS</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a single-arm study. Participating subjects will be treated with the Temporary Spur Stent System (TSS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Temporary Spur Stent System</intervention_name>
    <description>Participating subjects that meet inclusion and exclusion criteria will undergo treatment of infrapopliteal occlusions and stenoses with the Temporary Spur Stent System according to protocol guidelines</description>
    <arm_group_label>Treatment with TSS</arm_group_label>
    <other_name>G2-SPUR04X60, G2-SPUR03X60, G2-SPUR02x60</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is willing and able to provide informed consent and able to comply with the&#xD;
             study protocol.&#xD;
&#xD;
          2. Life expectancy &gt;1 year in the investigator's opinion&#xD;
&#xD;
          3. Subject is &gt; 18 years of age.&#xD;
&#xD;
          4. Subject is Rutherford class 3-5.&#xD;
&#xD;
          5. Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with&#xD;
             target lesion that can be successfully crossed with a guidewire.&#xD;
&#xD;
          6. Target lesion must meet lesion-specific criteria in pre-screening by angiography&#xD;
             (pre-screening with CTA, MRA or selective angiography may be performed prior to the&#xD;
             index procedure)&#xD;
&#xD;
          7. Target vessel(s) reconstitutes(s) at or above the medial malleolus, with the target&#xD;
             treated segment extending no more than 10 mm beyond the medial malleolus.&#xD;
&#xD;
             Note: If the anterior tibial or posterior tibial arteries are treated, there must be&#xD;
             inline flow to the foot.&#xD;
&#xD;
             If the peroneal artery is treated, there must be at least one collateral supplying the&#xD;
             foot.&#xD;
&#xD;
          8. Target lesion must begin no higher than the tibioperoneal trifurcation (popliteal&#xD;
             arteries excluded).&#xD;
&#xD;
          9. Target vessel reference diameter is measured to be between 2.0 mm to 4.5 mm in&#xD;
             diameter, assessed by one of the following methods after successful completion of&#xD;
             guidewire crossing of the lesion site:&#xD;
&#xD;
               1. Intravascular Ultrasound (IVUS)&#xD;
&#xD;
               2. Optical Coherence Tomography (OCT)&#xD;
&#xD;
               3. Quantitative Vascular Angiography (QVA).&#xD;
&#xD;
         10. Lesion length must be &gt; 30 mm and &lt; 150 mm.&#xD;
&#xD;
         11. Only one limb may be enrolled per subject. Up to two vessels may be treated per&#xD;
             subject; if required, a second modality may be used for treatment in the non-target&#xD;
             infrapopliteal vessel. Any treatment of the non-index vessel must be performed prior&#xD;
             to the use of the investigative device and only one artery may be treated with the&#xD;
             investigative device&#xD;
&#xD;
         12. The total treated segment is defined as the total length of artery treated with the&#xD;
             investigational device. Target treatment length is &lt;240 mm with a maximum segment of&#xD;
             150 mm separated by 30 mm of healthy tissue between treated lesions.&#xD;
&#xD;
         13. Successful pre-dilatation of the target lesion as outlined in the procedure&#xD;
             instructions, defined as resulting in stenosis &lt;50%, without resulting flow limiting&#xD;
             dissection (Type D or greater), thrombus, or aneurysm by angiography prior to the&#xD;
             insertion of the investigative device.&#xD;
&#xD;
         14. Iliac, SFA and popliteal inflow lesions can be treated using standard angioplasty&#xD;
             and/or an approved stent (no atherectomy) during the index procedure or &gt;30 days&#xD;
             prior. Inflow lesions treated intraprocedure must be treated first, prior to&#xD;
             consideration of treatment of infrapopliteal lesions. If pre-screening with&#xD;
             angiography, CTA, MRA, or ultrasound has been performed &lt;365 days prior to the&#xD;
             procedure, intra-procedure angiography of the aorto-iliac vasculature is not required,&#xD;
             however, the infrainguinal inflow must still be imaged using angiography during the&#xD;
             index procedure. Inflow lesions must have a healthy vessel segment of &gt;30 mm between&#xD;
             the study lesion and the treated segment, defined as less than 50% stenosis without&#xD;
             aneurysmal segments.&#xD;
&#xD;
         15. Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing,&#xD;
             however, the Temporary Spur Stent System must be deployed from antegrade access&#xD;
&#xD;
         16. For subjects with bilateral disease, planned treatment of the contralateral limb must&#xD;
             either be performed &gt;30 days prior to the index procedure or &gt; 14 days following the&#xD;
             index procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject unwilling or unlikely to comply with the appropriate follow up time for the&#xD;
             duration of the study in the opinion of the investigator.&#xD;
&#xD;
          2. Subject is pregnant or planning to become pregnant during the course of the trial.&#xD;
&#xD;
          3. Subject has an active infection that is not controlled at the time of the procedure,&#xD;
             including septicemia or bacteremia.&#xD;
&#xD;
          4. Subject has osteomyelitis or a heel wound.&#xD;
&#xD;
          5. Planned major (above the ankle) amputation of the target limb. A planned or previous&#xD;
             minor (transmetatarsal or digit amputation) is permitted&#xD;
&#xD;
          6. Recent myocardial infarction or stroke &lt; 90 days prior to the index procedure.&#xD;
&#xD;
          7. Heart failure with Ejection Fraction &lt; 35%&#xD;
&#xD;
          8. Impaired renal function (eGFR &lt;25 mL/min) within 30 days of procedure and subjects on&#xD;
             dialysis&#xD;
&#xD;
          9. Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica.&#xD;
&#xD;
         10. Subject receiving chronic or intravenous corticosteroid therapy.&#xD;
&#xD;
         11. Inability to tolerate dual antiplatelet and oral anticoagulation therapy.&#xD;
&#xD;
         12. Known allergies or sensitivities to heparin, antiplatelet, or other anticoagulant&#xD;
             therapies which could not be substituted, and/or paclitaxel or an allergy to contrast&#xD;
             media that cannot be adequately pre-treated prior to the index procedure.&#xD;
&#xD;
         13. The subject is currently enrolled in another investigational device or drug trial that&#xD;
             may interfere with the endpoints of this study.&#xD;
&#xD;
         14. Known allergy to nitinol or nickel.&#xD;
&#xD;
         15. Prior stent(s) within the target vessel, or bypass surgery of or within the target&#xD;
             vessel(s)&#xD;
&#xD;
         16. Target lesion is located within an aneurysm or associated with an aneurysm in the&#xD;
             vessel segment either proximal or distal to the target lesion. Inflow must also be&#xD;
             free of aneurysmal segments.&#xD;
&#xD;
         17. Previous treatment failure of inflow arteries (Iliac, SFA and popliteal) which&#xD;
             required a surgical procedure. Prior bypass above the level of the infrapopliteal&#xD;
             arteries is permitted.&#xD;
&#xD;
         18. Previous treatment of inflow lesions, if not treated during the index procedure, must&#xD;
             have been performed &gt;30 days prior to the index procedure.&#xD;
&#xD;
         19. Previous treatment of the target vessel &lt;30 days prior to index procedure&#xD;
&#xD;
         20. Angiographic evidence of thrombus within target limb.&#xD;
&#xD;
         21. Inability to obtain antegrade access in the limb from which the investigative device&#xD;
             can be deployed.&#xD;
&#xD;
         22. Extremely severe calcification classified as grade 4 as measured by the Peripheral&#xD;
             Academic Research Consortium (PARC) score or the Peripheral Arterial Calcium Scoring&#xD;
             System (PACSS) that, in the investigator's opinion, would not be amenable to PTA.&#xD;
&#xD;
         23. Type D dissections or greater incurred during pre-dilation or CTO crossing.&#xD;
&#xD;
         24. Significant (&gt;50%) stenosis of inflow arteries or unsuccessful treatment of inflow&#xD;
             lesions.&#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>Andrew Holden, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Auckland Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum Hochsauerland Klinik für Angiologie</name>
      <address>
        <city>Arnsberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitats Herzzentrum Bad Krozingen</name>
      <address>
        <city>Bad Krozingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RoMed Klinikum Rosenheim</name>
      <address>
        <city>Rosenheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Lugano Civico</name>
      <address>
        <city>Lugano</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>New Zealand</country>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.</citation>
    <PMID>24126108</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <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/NCT03807531
org study id: CP-002
nct id: NCT03807531
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the performance and safety of the Temporary Spur
      Stent System (TSS). The TSS is intended for use in conjunction with a commercially available
      drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic
      lesions.

      This study is a prospective, non-randomized, multicenter, single arm trial, with sites in New
      Zealand, Germany, and Switzerland.

      At least two and no more than 10 sites are expected to participate, with 100 subjects
      enrolled (no more than 40 at a single site).

      The study follow up will take place over a period of 365 days. A vessel recoil substudy will
      be included for a select group of subjects.
The purpose of this clinical study is to evaluate the performance and safety of the Temporary
      Spur Stent System (TSS) for subjects with infrapopliteal arterial disease.

      The Temporary Spur Stent System is intended for use in conjunction with a commercially
      available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or
      restenotic lesions.

      The TSS has been developed to provide another treatment option for patients with Peripheral
      Arterial Disease (PAD), and Critical Limb Ischemia (CLI).

      Up to 100 subjects will be treated with the Temporary Spur Stent System in conjunction with
      an approved Drug Coated Balloon (DCB). No less than 1 subject and no more than 40 subjects
      will be enrolled at a single site.

      A vessel recoil substudy is included in the trial. The purpose of this study is to evaluate
      vessel recoil in a select group of subjects (no more than 10 per site, up to 35 subjects in
      total). This will be conducted by obtaining measurements using Optical Coherence Tomography
      (OCT), Intravascular Ultrasound (IVUS), or Quantitative Vascular Analysis (QVA) of the target
      vessel during the index procedure.

      The statistical analysis for this trial will use as a comparator a performance goal derived
      from a meta-analysis of infrapopliteal balloon angioplasty. Descriptive statistics may be
      used to describe other data points.

      Subjects will be asked to participate in a baseline evaluation visit, the index procedure, a
      30 day follow up visit, a 90 day follow up visit, a 180 day follow up visit, and a 365 day
      follow up visit. The baseline evaluation and index procedure visits may be combined. At each
      follow up visit, the subject will undergo a physical exam with wound evaluation (if
      applicable) including pictures, a medication history and compliance review, Ankle Brachial
      and Toe Brachial Indices (ABI and TBI), a duplex ultrasound of the treated limb, review of
      symptoms, and Adverse Events (AE) assessment. Subjects may choose to withdraw from the study
      at any time, for any reason. If subjects choose to withdraw, they will be asked to undergo an
      unscheduled study visit consisting of the aforementioned procedures.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Multicenter, non-randomized, single-arm study
primary purpose: Treatment
masking: None (Open Label)
measure: Primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization)
time frame: 6 months
description: The primary performance endpoint will be primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization).
measure: Freedom from device and procedure-related death through 30 days post-procedure
time frame: 30 days
description: The primary safety endpoint is freedom from device and procedure-related death through 30 days post-procedure
measure: Freedom from clinically driven target lesion revascularization through 6 months post procedure.
time frame: 6 months
description: The secondary efficacy endpoint is freedom from clinically driven target lesion revascularization through 6 months post procedure.
measure: Decrease in Rutherford class score at 3, 6 and 12 months.
time frame: 3, 6, and 12 months
description: The second secondary efficacy measurement is decrease in Rutherford class score at 3, 6 and 12 months. Rutherford score is a classification system for patients with peripheral vascular disease.
Categories are numbered from 0 to 6, with 0 being asymptomatic, and 6 being major tissue loss, functional foot no longer salvageable. Higher values are therefore considered a worse outcome.
Rutherford class zero: No symptoms; Rutherford class 1: Mild Claudication (minimal leg pain with ambulation) symptoms; Rutherford Class 2: Moderate Claudication (moderate leg pain with ambulation); Rutherford Class 3: Severe claudication (severe leg pain with ambulation); Rutherford Class 4: Ischemic Rest pain (leg pain at rest); Rutherford Class 5: Minor tissue loss (nonhealing ulcer, focal gangrene, diffuse pedal ischemia); Rutherford class 6: Major tissue loss (extending above the transmetatarsal TM level, functional foot no longer salvageable.
measure: Wound healing for subjects with Rutherford class 5 at 6 and 12 months, as assessed by the investigator using WIfI score and descriptive characteristics, including change in wound size measured by any decrease in wound surface area.
time frame: 6 and 12 months
description: The third secondary efficacy endpoint is wound healing for subjects with Rutherford class 5 at 6 and 12 months, as assessed by the investigator using WIfI score and descriptive characteristics, including change in wound size measured by any decrease in wound surface area.
The WIfI classification scoring system is a grading system using a composite score of wound (W), ischemia (I), and foot infection (fi). These three different categories are graded from 0 to 3 with 0 being the best and 3 being the worst.
The total score will be provided (clinical stage 1-5), which is used to estimate the risk for major amputation at one year. Patients with a score of 1 are considered low risk, and patients with a score of 5 are considered high risk (foot not salvageable). Therefore, higher values are considered a worse outcome.
The composite score is calculated by adding up the score from each category.
arm group label: Treatment with TSS
arm group type: Other
description: This is a single-arm study. Participating subjects will be treated with the Temporary Spur Stent System (TSS)
intervention type: Device
intervention name: Temporary Spur Stent System
description: Participating subjects that meet inclusion and exclusion criteria will undergo treatment of infrapopliteal occlusions and stenoses with the Temporary Spur Stent System according to protocol guidelines
arm group label: Treatment with TSS
other name: G2-SPUR04X60, G2-SPUR03X60, G2-SPUR02x60
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Holden, MBChB
role: Principal Investigator
affiliation: Auckland Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: New Zealand
country: Switzerland
citation: Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
PMID: 24126108
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
sharing ipd: No