Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization

Inclusion Criteria

• •Inclusion Screening Criteria:
• •Age ≥18 years and ≤85 years at study enrollment
• •Subject has been informed of the nature of the study, agrees to participate and has signed an IRB-approved consent form
• •Subject is ambulatory
• •Female subjects 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 (See Section 12.2) for one month preceding and 12 months following study treatment
• •Subject has documented moderate to severe claudication (Rutherford 2-3) or Critical Limb Ischemia (CLI) with rest pain (Rutherford 4) in the target limb due to arterial stenosis within the superficial femoral and/or popliteal artery
• •Life expectancy \>2 years in the Investigator's opinion Angiographic Criteria (Target Lesion Definition)
• •Target vessel reference diameter ≥3 mm and ≤8 mm
• •Single or multiple de novo atherosclerotic or restenotic lesion(s) with ≥70% narrowing in the superficial femoral or popliteal artery meeting the following criteria:
• •* The target lesion must be ≤20 cm in total length
• •* The target lesion does not have more than 5 cm of contiguous length of intervening normal artery
• •* The target lesion does not cross into the common femoral artery or tibeoperoneal trunk
• •* The target lesion is located at least 10 mm away from any previously placed stent or graft
• •Successful wire crossing (sub-intimal is allowed) and revascularization by balloon angioplasty of the target lesion with less than 30% residual stenosis and run-off in at least one patent vessel into the foot
• •Exclusion Screening Criteria:
• •Subject is already enrolled in another clinical study of systemic drug therapy or another device study that has not completed its primary endpoint
• •Subject unwilling or unlikely to comply with visit schedule
• •Subjects who are incapable of providing consent and/or incapable of understanding the nature, significance and implications of the clinical trial
• •Subject is already receiving, has received in prior 2 months, or is planned in the 6 months after index procedure to receive systemic immunotherapy, chemotherapy, or systemic steroids (however, steroid pre-treatment for contrast allergy, inhaled steroids for asthma treatment or topical steroid uses are allowed)
• •Subject is receiving chronic anticoagulation therapy e.g. warfarin (note: chronic antiplatelet therapy, e.g. aspirin and clopidigrel, and procedural anticoagulation therapy, e.g. heparin or bivalirudin, are allowed)
• •Subject 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 or any history of intracerebral hemorrhage
• •Any surgical or endovascular procedure (not including staged revascularization in the target limb, e.g. inflow revascularization prior to index procedure or below-knee revascularization after the index procedure) performed within 14 days prior to the index procedure or planned within 30 days post index procedure
• •Planned amputation in the target limb
• •Active foot infection or ischemic foot wound
• •Inability to receive temsirolimus, dexamethasone 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 Angiographic/Procedural Criteria
• •Hemodynamically significant inflow lesion (≥50% DS) or occlusion in the ipsilateral iliac artery 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)
• •Prior stent placement in target lesion (i.e., in-stent restenosis)
• •Target lesion restenosis of any kind within 6 months of a prior intervention
• •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 during the index procedure or during the previous 12 months
• •Use of atherectomy devices in the target lesion during the index procedure
• •Aneurysm in the target vessel
• •Acute thrombus in the target limb
• •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