ELITE-BTK

This trial is for patients with chronic limb-threatening ischemia and evaluates the safety and efficacy of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold and Delivery System in the treatment of CLTI due to de novo or restenotic lesions in the infrapopliteal arteries compared to standard PTA (uncoated balloon angioplasty) alone. This study is randomized 1:1 with intervention and control standard of care group. Study duration will be approximately 3 years post procedure.

In order to participate you must meet the following criteria:

• Present with Rutherford category 4 or 5.
• Agree to complete all protocol-required follow-up visits, including all required imaging protocols (DUS, angiograms, wound imaging).

You will be excluded from the study if any of the following criteria apply to you:

• Have severe medical comorbidities. (i.e., history of stroke or MI within 3 months, chronic or acute renal failure, or active cancer within 1 year of the procedure).
• Have uncontrolled diabetes with HbA1c > 10%.
• Have prior major amputation (above or below the knee or above the ankle) involving the target limb or planned surgical or endovascular procedure within 6 months following the index procedure.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.