MOTIV BTK Randomized Controlled Trial

Exclusion Criteria

• •Subjects will be excluded if any of the following criteria apply:
• •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.
• •Subjects will be excluded if any of the following criteria apply:
• •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