<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/NCT04433572</url>
  </required_header>
  <id_info>
    <org_study_id>CIP0216</org_study_id>
    <nct_id>NCT04433572</nct_id>
  </id_info>
  <brief_title>Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee</brief_title>
  <acronym>TANGO-3</acronym>
  <official_title>Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the Incidence of Ischemia-Driven Major Amputation, Clinically Driven Target Lesion Revascularization, and Clinically Relevant Target Lesion Occlusion After Revascularization of Lesions Below the Knee in Patients With Symptomatic Rutherford 3-5 Peripheral Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mercator MedSystems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mercator MedSystems, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of&#xD;
      Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major&#xD;
      amputation, clinically driven target lesion revascularization, and clinically relevant target&#xD;
      lesion occlusion after revascularization of lesions below the knee in patients with&#xD;
      symptomatic Rutherford 3-5 peripheral artery disease. The primary safety endpoint will be&#xD;
      gathered at 1-month post-index procedure. The primary efficacy endpoint will be gathered at 6&#xD;
      months post-index procedure. Participants will be followed for up to 5 years post-index&#xD;
      procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After completion of revascularization therapy and any decision to place stents, participants&#xD;
      will be qualified for final enrollment in the study and will be randomized 1:1 and treated&#xD;
      with the investigational drug or placebo. Any stents will be placed only after randomization,&#xD;
      assignment, and adventitial drug therapy, although any stenting decisions (other than for&#xD;
      treatment of AEs) must be made prior to randomization and adventitial drug delivery in order&#xD;
      to avoid bias toward or against stenting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2025</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Block randomization will be stratified for Rutherford 3 and for Rutherford 4/5 participants such that each strata will be randomized 1:1. Block randomization will also be stratified by site such that each site will be assigned a 1:1 randomization.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The active vials and placebo vials will be identical in size, color and appearance on reconstitution. Investigators and participants will be blinded to assignment. Any stents will be placed only after randomization, assignment, and adventitial drug therapy, although any stenting decisions (other than for treatment of AEs) must be made prior to randomization and adventitial drug delivery in order to avoid bias toward or against stenting.&#xD;
Participants will not be told of their treatment assignment until after they complete the trial.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from Cinical Relevant Target Lesion Failure</measure>
    <time_frame>6 Months</time_frame>
    <description>Superiority of treatment vs. control group in the composite freedom from the following:&#xD;
Clinically Relevant Target Lesion Occlusion&#xD;
Clinically Driven Target Lesion Revascularization&#xD;
Ischemia-Driven Major Amputation of the Target Limb</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MALE + POD</measure>
    <time_frame>30 Days</time_frame>
    <description>Noninferiority of treatment vs. control groups in the composite freedom from Major Adverse Limb Event (MALE) in the target limb or Perioperative Death (POD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from Target Lesion Failure</measure>
    <time_frame>6 Months</time_frame>
    <description>Superiority of treatment vs. control group in the composite freedom from the following:&#xD;
Target Lesion Occlusion&#xD;
Clinically Driven Target Lesion Revascularization&#xD;
Ischemia-Driven Major Amputation of the target limb</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine non-inferiority in long-term mortality rate</measure>
    <time_frame>12, 24, 36, 48, 60 months</time_frame>
    <description>Death at the following time points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine non-inferiority in freedom from all-cause death or major adverse limb event.</measure>
    <time_frame>30 days, 6, 12 months</time_frame>
    <description>Composite of all-cause death or MALE of the target limb</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine non-inferiority in amputation-free survival.</measure>
    <time_frame>30 days, 6, 12, 24 months</time_frame>
    <description>Freedom from death and ischemia-driven major amputation of the target limb</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability will be assessed from overall rate of adverse events (subclassified as major, serious, non-serious, unanticipated, revascularization procedure-related, device-related and drug-related).</measure>
    <time_frame>30 days, 6, 12, 24 months</time_frame>
    <description>AEs/ARs will be categorized into one of the following:&#xD;
MALE of the target limb&#xD;
Non-MALE target limb SAE/SAR&#xD;
Other SAE/SAR&#xD;
Non-serious AE/AR&#xD;
AEs/ARs will further be classified as:&#xD;
Expected&#xD;
UADE&#xD;
SUSAR&#xD;
AEs/ARs will also be classified for relatedness (definitely, probably, possibly or not) to the following:&#xD;
Revascularization procedure&#xD;
Use of the Bullfrog device&#xD;
The study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the individual components of the primary and secondary endpoints (ischemia-driven major amputation, clinically driven target lesion revascularization, clinically relevant target lesion occlusion or all target lesion occlusion)</measure>
    <time_frame>6, 12, 24 months</time_frame>
    <description>Taken individually:&#xD;
Ischemia-driven major amputation of the target limb&#xD;
CD-TLR&#xD;
Clinically relevant target lesion occlusion&#xD;
Any target lesion occlusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from major adverse limb events</measure>
    <time_frame>30 days, 6, 12, 24 months</time_frame>
    <description>MALE of the target limb</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of the following wound healing measures</measure>
    <time_frame>30 days, 6, 12 months</time_frame>
    <description>Total size of foot wounds on the target limb, percent and absolute change from baseline&#xD;
Status of foot wounds on the target limb&#xD;
Unassisted wound healing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in unplanned minor amputations</measure>
    <time_frame>30 days, 6, 12 months</time_frame>
    <description>Unplanned minor amputation rate, overall and by level (forefoot, midfoot, hindfoot)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutherford score improvement</measure>
    <time_frame>30 days, 6, 12, 24 months</time_frame>
    <description>Rutherford category and change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WIfI score improvement</measure>
    <time_frame>30 days, 6, 12, 24 months</time_frame>
    <description>WIfI category and change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of hemodynamic improvement measures (ABI, TBI and toe pressure)</measure>
    <time_frame>30 days, 6, 12, 24 months</time_frame>
    <description>Ankle-brachial index and change from baseline&#xD;
Toe-brachial index and change from baseline&#xD;
Toe pressure and change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported quality of life benefits (VascuQoL)</measure>
    <time_frame>30 days, 6, 12, 24 months</time_frame>
    <description>VascuQoL results and change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes (walking impairment questionnaire) benefits</measure>
    <time_frame>30 days, 6, 12, 24 months</time_frame>
    <description>WIQ results and change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary and primary assisted patency rates</measure>
    <time_frame>30 days, 6, 12, 24 months</time_frame>
    <description>Primary patency rate&#xD;
Primary assisted patency rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary and secondary sustained clinical improvement rates</measure>
    <time_frame>30 days, 6, 12, 24 months</time_frame>
    <description>Primary sustained clinical improvement rate&#xD;
Secondary sustained clinical improvement rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <condition>Critical Limb Ischemia</condition>
  <arm_group>
    <arm_group_label>Temsirolimus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Temsirolimus delivered to adventitia and perivascular tissue after primary revascularization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline placebo delivered to adventitia and perivascular tissue after primary revascularization</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temsirolimus</intervention_name>
    <description>0.1 mg/mL temsirolimus, including contrast medium with approximately 75 mg iodine per mL. The dosage will be delivered in a volume of 0.50 mL per cm of target lesion length, up to 30 cm, with +50% allowance for anatomical considerations; for a total volume of up to 22.5 mL and a total dose of up to 2.25 mg in participants assigned to treatment. The same volumes of comparator agent will be delivered in control participants.</description>
    <arm_group_label>Temsirolimus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline placebo</intervention_name>
    <description>Saline placebo, including contrast medium with approximately 75 mg iodine per mL. The dosage will be delivered in a volume of 0.50 mL per cm of target lesion length, up to 30 cm, with +50% allowance for anatomical considerations; for a total volume of up to 22.5 mL and a total dose of up to 2.25 mg in participants assigned to treatment. The same volumes of comparator agent will be delivered in control participants.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Age ≥18 years and &lt;90 years&#xD;
&#xD;
          -  Patient has documented severe claudication (Rutherford 3) or chronic Critical Limb&#xD;
             Ischemia (CLI) (Rutherford 4-5) in the target limb due to arterial stenosis between&#xD;
             the knee joint space and the ankle joint prior to the study procedure&#xD;
&#xD;
          -  Life expectancy &gt;1 year in the Investigator's opinion&#xD;
&#xD;
          -  Patient has been informed of the nature of the study, agrees to participate, agrees to&#xD;
             the follow-up schedule, and has signed an IRB approved consent form&#xD;
&#xD;
          -  Female patients of childbearing potential have a negative pregnancy test ≤7 days&#xD;
             before the procedure and are willing to use a highly effective method of birth control&#xD;
             for one month preceding and 12 months following study treatment&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Patient is already enrolled in another clinical study of systemic drug therapy or&#xD;
             another device study that has not completed its primary endpoint, including prior&#xD;
             enrollment in this study&#xD;
&#xD;
          -  Patient is unwilling or unlikely to comply with visit schedule&#xD;
&#xD;
          -  Patient is incapable of providing consent and/or incapable of understanding the&#xD;
             nature, significance and implications of the clinical trial&#xD;
&#xD;
          -  Patient is already receiving or planned to receive systemic immunotherapy or&#xD;
             chemotherapy&#xD;
&#xD;
          -  Patient is at high risk of thrombosis and taking systemic anticoagulant therapy that&#xD;
             is unable to be withheld during the procedure&#xD;
&#xD;
          -  Patient has a CNS tumor or elevated risk for intracerebral bleeding and is receiving&#xD;
             chronic anticoagulation therapy e.g. warfarin or oral anticoagulant (note: chronic&#xD;
             antiplatelet therapy, e.g. aspirin and clopidogrel, and procedural anticoagulation&#xD;
             therapy, e.g. heparin or bivalirudin, are allowed)&#xD;
&#xD;
          -  Recent (&lt;30 days prior to study procedure) myocardial infarction&#xD;
&#xD;
          -  Cerebrovascular accident &lt;60 days prior to the study procedure or any history of&#xD;
             intracerebral hemorrhage&#xD;
&#xD;
          -  Any surgical or endovascular procedure performed within 14 days prior to the index&#xD;
             procedure or planned within 30 days post index procedure is exclusionary; allowable&#xD;
             exceptions to this exclusion include the following:&#xD;
&#xD;
               1. concurrent procedures during the index procedure&#xD;
&#xD;
               2. prior staged revascularization in the target limb, e.g. for inflow&#xD;
                  revascularization within 14 days of and prior to the index procedure&#xD;
&#xD;
          -  Planned major (above the ankle) target limb amputation&#xD;
&#xD;
          -  Active foot infection, including osteomyelitis of the metatarsal or more proximal&#xD;
             region; allowable exceptions to this exclusion include the following:&#xD;
&#xD;
               1. osteomyelitis in the toes&#xD;
&#xD;
               2. mild cellulitis around the perimeter of gangrene&#xD;
&#xD;
               3. small ulcers (&lt;25mm largest diameter)&#xD;
&#xD;
          -  Inability to receive temsirolimus or iodinated contrast medium due to labeled&#xD;
             contra-indications or known sensitivity reactions&#xD;
&#xD;
          -  Stage 3 (per SVS WIfI classification) or worse heel ulcers or heel ulcers that are&#xD;
             determined to be primarily neuropathic in nature or non-ischemic in origin&#xD;
&#xD;
          -  Risk of amputation based on WIfI clinical staging = HIGH&#xD;
&#xD;
          -  Patient has active viral infection of SARS-CoV-2 or active disease diagnosis of&#xD;
             COVID-19 (must be determined within 7 days of index procedure)&#xD;
&#xD;
          -  Patient has a bilirubin level of &gt;1.5xULN&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR, calculated from serum creatinine using an&#xD;
             isotope dilution mass spectrometry (IDMS)-traceable equation) less than 30 mL/min,&#xD;
             except for patients with end stage renal disease on chronic hemodialysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kirk Seward, PhD</last_name>
    <phone>(510) 614-4555</phone>
    <email>kseward@mercatormed.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</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>Chronic Limb-Threatening Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sirolimus</mesh_term>
    <mesh_term>Temsirolimus</mesh_term>
    <mesh_term>MTOR Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No, there is not a plan to make individual participant data available to other researchers.</ipd_description>
  </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/NCT04433572
org study id: CIP0216
nct id: NCT04433572
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of
      Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major
      amputation, clinically driven target lesion revascularization, and clinically relevant target
      lesion occlusion after revascularization of lesions below the knee in patients with
      symptomatic Rutherford 3-5 peripheral artery disease. The primary safety endpoint will be
      gathered at 1-month post-index procedure. The primary efficacy endpoint will be gathered at 6
      months post-index procedure. Participants will be followed for up to 5 years post-index
      procedure.
After completion of revascularization therapy and any decision to place stents, participants
      will be qualified for final enrollment in the study and will be randomized 1:1 and treated
      with the investigational drug or placebo. Any stents will be placed only after randomization,
      assignment, and adventitial drug therapy, although any stenting decisions (other than for
      treatment of AEs) must be made prior to randomization and adventitial drug delivery in order
      to avoid bias toward or against stenting.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Block randomization will be stratified for Rutherford 3 and for Rutherford 4/5 participants such that each strata will be randomized 1:1. Block randomization will also be stratified by site such that each site will be assigned a 1:1 randomization.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The active vials and placebo vials will be identical in size, color and appearance on reconstitution. Investigators and participants will be blinded to assignment. Any stents will be placed only after randomization, assignment, and adventitial drug therapy, although any stenting decisions (other than for treatment of AEs) must be made prior to randomization and adventitial drug delivery in order to avoid bias toward or against stenting.
Participants will not be told of their treatment assignment until after they complete the trial.
measure: Freedom from Cinical Relevant Target Lesion Failure
time frame: 6 Months
description: Superiority of treatment vs. control group in the composite freedom from the following:
Clinically Relevant Target Lesion Occlusion
Clinically Driven Target Lesion Revascularization
Ischemia-Driven Major Amputation of the Target Limb
measure: MALE + POD
time frame: 30 Days
description: Noninferiority of treatment vs. control groups in the composite freedom from Major Adverse Limb Event (MALE) in the target limb or Perioperative Death (POD)
measure: Freedom from Target Lesion Failure
time frame: 6 Months
description: Superiority of treatment vs. control group in the composite freedom from the following:
Target Lesion Occlusion
Clinically Driven Target Lesion Revascularization
Ischemia-Driven Major Amputation of the target limb
measure: To determine non-inferiority in long-term mortality rate
time frame: 12, 24, 36, 48, 60 months
description: Death at the following time points
measure: To determine non-inferiority in freedom from all-cause death or major adverse limb event.
time frame: 30 days, 6, 12 months
description: Composite of all-cause death or MALE of the target limb
measure: To determine non-inferiority in amputation-free survival.
time frame: 30 days, 6, 12, 24 months
description: Freedom from death and ischemia-driven major amputation of the target limb
measure: Safety and tolerability will be assessed from overall rate of adverse events (subclassified as major, serious, non-serious, unanticipated, revascularization procedure-related, device-related and drug-related).
time frame: 30 days, 6, 12, 24 months
description: AEs/ARs will be categorized into one of the following:
MALE of the target limb
Non-MALE target limb SAE/SAR
Other SAE/SAR
Non-serious AE/AR
AEs/ARs will further be classified as:
Expected
UADE
SUSAR
AEs/ARs will also be classified for relatedness (definitely, probably, possibly or not) to the following:
Revascularization procedure
Use of the Bullfrog device
The study drug
measure: Change of the individual components of the primary and secondary endpoints (ischemia-driven major amputation, clinically driven target lesion revascularization, clinically relevant target lesion occlusion or all target lesion occlusion)
time frame: 6, 12, 24 months
description: Taken individually:
Ischemia-driven major amputation of the target limb
CD-TLR
Clinically relevant target lesion occlusion
Any target lesion occlusion
measure: Freedom from major adverse limb events
time frame: 30 days, 6, 12, 24 months
description: MALE of the target limb
measure: Composite of the following wound healing measures
time frame: 30 days, 6, 12 months
description: Total size of foot wounds on the target limb, percent and absolute change from baseline
Status of foot wounds on the target limb
Unassisted wound healing
measure: Reduction in unplanned minor amputations
time frame: 30 days, 6, 12 months
description: Unplanned minor amputation rate, overall and by level (forefoot, midfoot, hindfoot)
measure: Rutherford score improvement
time frame: 30 days, 6, 12, 24 months
description: Rutherford category and change from baseline
measure: WIfI score improvement
time frame: 30 days, 6, 12, 24 months
description: WIfI category and change from baseline
measure: Composite of hemodynamic improvement measures (ABI, TBI and toe pressure)
time frame: 30 days, 6, 12, 24 months
description: Ankle-brachial index and change from baseline
Toe-brachial index and change from baseline
Toe pressure and change from baseline
measure: Patient reported quality of life benefits (VascuQoL)
time frame: 30 days, 6, 12, 24 months
description: VascuQoL results and change from baseline
measure: Patient reported outcomes (walking impairment questionnaire) benefits
time frame: 30 days, 6, 12, 24 months
description: WIQ results and change from baseline
measure: Primary and primary assisted patency rates
time frame: 30 days, 6, 12, 24 months
description: Primary patency rate
Primary assisted patency rate
measure: Primary and secondary sustained clinical improvement rates
time frame: 30 days, 6, 12, 24 months
description: Primary sustained clinical improvement rate
Secondary sustained clinical improvement rate
arm group label: Temsirolimus
arm group type: Active Comparator
description: Temsirolimus delivered to adventitia and perivascular tissue after primary revascularization
arm group label: Placebo
arm group type: Placebo Comparator
description: Saline placebo delivered to adventitia and perivascular tissue after primary revascularization
intervention type: Drug
intervention name: Temsirolimus
description: 0.1 mg/mL temsirolimus, including contrast medium with approximately 75 mg iodine per mL. The dosage will be delivered in a volume of 0.50 mL per cm of target lesion length, up to 30 cm, with +50% allowance for anatomical considerations; for a total volume of up to 22.5 mL and a total dose of up to 2.25 mg in participants assigned to treatment. The same volumes of comparator agent will be delivered in control participants.
arm group label: Temsirolimus
intervention type: Drug
intervention name: Saline placebo
description: Saline placebo, including contrast medium with approximately 75 mg iodine per mL. The dosage will be delivered in a volume of 0.50 mL per cm of target lesion length, up to 30 cm, with +50% allowance for anatomical considerations; for a total volume of up to 22.5 mL and a total dose of up to 2.25 mg in participants assigned to treatment. The same volumes of comparator agent will be delivered in control participants.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Kirk Seward, PhD
phone: (510) 614-4555
email: kseward@mercatormed.com
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia
mesh term: Sirolimus
mesh term: Temsirolimus
mesh term: MTOR Inhibitors
sharing ipd: No
ipd description: No, there is not a plan to make individual participant data available to other researchers.