Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee

This study is testing a drug called temsirolimus, delivered directly into the wall of blocked arteries in the lower leg (below the knee), as a way to prevent these arteries from re-narrowing after they have been opened up with angioplasty or atherectomy. Peripheral artery disease (PAD) causes arteries in the legs to narrow due to plaque buildup, leading to pain, wounds that won't heal, and sometimes amputation. While procedures can open these arteries, they often re-close over time — a process called restenosis. By delivering an anti-restenosis drug directly to the artery wall using a special catheter device (the Bullfrog Micro-Infusion Device), researchers hope to prevent this re-narrowing and improve long-term outcomes for patients with serious limb-threatening ischemia. The drug is not in the bloodstream systemically — it goes directly into the target vessel wall. You may be eligible if: - You are 18 or older with severe leg claudication or chronic limb-threatening ischemia - You have specific below-knee artery lesions meeting the study criteria - You have successfully undergone revascularization (artery reopening) during the index procedure - You are able to walk (with assistance is acceptable) You may NOT be eligible if: - You are pregnant or planning to become pregnant in the first 12 months - You have a life expectancy of 1 year or less - You are on systemic immunosuppressive therapy or chemotherapy - You have had a heart attack within the past 30 days or stroke within 90 days - You have severe kidney disease (eGFR below 30, unless on dialysis) - You have signs of serious active infection or sepsis Talk to your doctor to see if this trial is right for you.