MOTIV BTK Randomized Controlled Trial

Eligibility Criteria

• 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.
• 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 (\<50% diameter stenosis by visual assessment) outflow vessel.
• 1. Subject has severe medical comorbidities or other medical, social or psychological condition that could limit subject's ability to participate in the study or is associated with a life expectancy of less than 1 year.
• 2. Subject has documented history of stroke within 3 months prior to the procedure.
• 3. Subject has history of MI, within 30 days prior to the planned index procedure.
• 4. Subjects with renal failure (estimated Glomerular Filtration Rate \[eGFR\] \< 30 ml/min).
• 5. Subject has non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis).
• 6. Subject presents with CLI classified as Rutherford category 6.
• 7. Subject has acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure with associated loss of sensation or motor function.
• 8. Subject had a major amputation that occurred less than one year prior to enrollment and subject is not independently ambulating.
• 9. Subject has a planned major amputation (of either leg).
• 10. Subject has had, or currently requires, surgical revascularization in the target vessel.
• 11. Subject has a planned use of adjunctive primary treatment modalities (e.g., radiation therapy, stents) in below-the-knee vessels; plaque modification technology such as the use of atherectomy, laser or cutting balloons is permitted.
• 12. Subject has any systemic infection or immunocompromised state.
• 13. Subject has a coagulation disorder, including hypercoagulability; or the subject has contraindication to anticoagulant or antiplatelet therapy.
• 14. Subject has a known history of heparin-induced thrombocytopenia (HIT) type II.
• 15. Subject has known allergy or sensitivity to scaffold or scaffold components.
• 16. Subject has a known allergy or sensitivity to contrast media that cannot be adequately pre-treated.
• 17. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
• 18. Subject is currently participating in another investigational drug or device clinical study that has not yet met its primary endpoint.
• 1. Target lesion(s) with severe calcification (PARC defined).
• 2. Target lesion(s) will be subjected to significant bending and axial compression.
• 3. Target lesion(s) located in highly tortuous vessels.
• 4. Target lesion(s) previously stented (in-stent restenotic lesion).
• 5. Target vessel(s) has any other significant lesions (≥50% diameter stenosis by visual assessment) that is not a target lesion.
• 6. Target vessel previously treated within 3 months prior to index procedure
• 7. Angiographic evidence of thromboembolism in target limb
• 8. Inflow-limiting arterial stenoses are unsuccessfully treated or left untreated