Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee (TANGO)

Exclusion Criteria

• •Screening Criteria
• •Patient is already enrolled in another clinical study of systemic drug therapy or another device study that has not completed its primary endpoint
• •Patient unwilling or unlikely to comply with visit schedule
• •Patients who are 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, chemotherapy, or steroids (however, inhaled steroids for asthma treatment or topical steroid uses are allowed)
• •Patient has a bilirubin level of \>1.5xULN
• •Recent (\<30 days prior to study procedure) myocardial infarction
• •Cerebrovascular accident \<60 days prior to the study procedure
• •Planned major (above the ankle) target limb amputation
• •Active foot infection; however, osteomyelitis in the toes or mild cellulitis around the perimeter of gangrene or small ulcers (\<25mm) are not exclusions, but osteomyelitis of the metatarsal or more proximal region would be exclusionary
• •Inability to receive temsirolimus or iodinated contrast medium due to labeled contra-indications or known sensitivity reactions 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
• •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
• •Angiographic/Procedural Criteria
• •Hemodynamically significant inflow lesion (≥50% DS) or occlusion in the ipsilateral iliac, SFA, or popliteal arteries (P1 and P2) in which there is failure to successfully treat and obtain a \<30% residual stenosis post-revascularization, with bailout stenting as needed (in-flow lesions should be treated prior to treating the target lesion)
• •Target lesion length is \>30 cm as measured from proximal normal vessel to distal normal vessel
• •Total length of lesions treated during the case (including target lesion, inflow lesions, and other non-target lesions) \>30 cm
• •Use of alternative therapy, e.g. radiation therapy, drug-eluting stents (DES) or drug-eluting balloon/drug-coated balloons (DEB/DCB) as part of the target lesion treatment or during the previous 2 months within the target lesion
• •Previously implanted stent in the TL(s)
• •Aneurysm in the target vessel
• •Acute thrombus in the target limb
• •Failure to cross the TL with a guide wire; however, subintimal wire crossing is allowed
• •Heavy eccentric or concentric calcification at target lesion, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Device needle through the vessel wall