MOTIV BTK Randomized Controlled Trial

Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.

Inclusion Criteria: Clinical Inclusion Criteria Subjects must meet all of the following criteria to be eligible for enrollment in the trial: 1. Subject is at least 18 years of age. 2. Subject presents with symptomatic CLI classified as Rutherford category 4 or 5. 3. Subject agrees to comply with all-protocol specified procedures and follow-up assessments. 4. Subject or subject's legal representative signs an IRB/EC approved informed consent form prior to study participation. Angiographic Inclusion Criteria Subjects must meet the following criteria to be eligible for participation in the study: 1. Significant stenosis (\>70% diameter stenosis by visual estimate) of one or two native infrapopliteal lesions; if two lesions, each lesion should be in a separate infrapopliteal vessel in the same limb. Unstented restenotic lesions are permitted. 2. Target vessel diameter between 2.5 mm and 3.75 mm and able to be treated with the available device size matrix. 3. Each target lesion is treatable by a maximum of 3 scaffolds, and all target lesions(s) combined must be treatable by a maximum of 4 scaffolds. 4. Total scaffold length among all target lesions must not exceed 120 mm (total sirolimus drug dose of 720 µg). 5. Target lesion(s) must be at least 4 cm above the ankle joint 6. Target lesion(s) are located in an area that may be stented without blocking access to patent main branches. 7. A patent inflow artery from the aorta to the target lesion free from significant stenosis (≥50% diameter stenosis by visual estimate) must be present, as confirmed by angiography. 8. Significant lesions (≥50% diameter stenosis) in inflow arteries must be treated successfully (per physician's assessment) using standard of care treatment prior to enrollment; inflow lesion treatment may be performed during the index procedure. 9. Target vessel(s) reconstitute(s) at or above the ankle or displays normal terminal branching with inline flow to at least one patent (\