Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee (TANGO-3)

This is an interventional treatment trial for Peripheral Artery Disease Read More

Inclusion Criteria

• Age ≥18 years and <90 years
• Patient has documented severe claudication (Rutherford 3) or chronic Critical Limb Ischemia (CLI) (Rutherford 4-5) in the target limb due to arterial stenosis between the knee joint space and the ankle joint prior to the study procedure
• Life expectancy >1 year in the Investigator's opinion
• Patient has been informed of the nature of the study, agrees to participate, agrees to the follow-up schedule, and has signed an IRB approved consent form
• Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a highly effective method of birth control for one month preceding and 12 months following study treatment

Exclusion Criteria

• Patient is already enrolled in another clinical study of systemic drug therapy or another device study that has not completed its primary endpoint, including prior enrollment in this study
• Patient is unwilling or unlikely to comply with visit schedule
• Patient is incapable of providing consent and/or incapable of understanding the nature, significance and implications of the clinical trial
• Patient is already receiving or planned to receive systemic immunotherapy or chemotherapy
• Patient is at high risk of thrombosis and taking systemic anticoagulant therapy that is unable to be withheld during the procedure
• Patient has a CNS tumor or elevated risk for intracerebral bleeding and is receiving chronic anticoagulation therapy e.g. warfarin or oral anticoagulant (note: chronic antiplatelet therapy, e.g. aspirin and clopidogrel, and procedural anticoagulation therapy, e.g. heparin or bivalirudin, are allowed)
• Recent (<30 days prior to study procedure) myocardial infarction
• Cerebrovascular accident <60 days prior to the study procedure or any history of intracerebral hemorrhage

• Any surgical or endovascular procedure performed within 14 days prior to the index procedure or planned within 30 days post index procedure is exclusionary; allowable exceptions to this exclusion include the following:

  1. concurrent procedures during the index procedure
  2. prior staged revascularization in the target limb, e.g. for inflow revascularization within 14 days of and prior to the index procedure
• Planned major (above the ankle) target limb amputation

• Active foot infection, including osteomyelitis of the metatarsal or more proximal region; allowable exceptions to this exclusion include the following:

  1. osteomyelitis in the toes
  2. mild cellulitis around the perimeter of gangrene
  3. small ulcers (<25mm largest diameter)
• Inability to receive temsirolimus or iodinated contrast medium due to labeled contra-indications or known sensitivity reactions
• Stage 3 (per SVS WIfI classification) or worse heel ulcers or heel ulcers that are determined to be primarily neuropathic in nature or non-ischemic in origin
• Risk of amputation based on WIfI clinical staging = HIGH
• Patient has active viral infection of SARS-CoV-2 or active disease diagnosis of COVID-19 (must be determined within 7 days of index procedure)
• Patient has a bilirubin level of >1.5xULN
• Estimated glomerular filtration rate (eGFR, calculated from serum creatinine using an isotope dilution mass spectrometry (IDMS)-traceable equation) less than 30 mL/min, except for patients with end stage renal disease on chronic hemodialysis