• Subject must provide written informed consent prior to any clinical investigation related procedure

• Subject has symptomatic Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5

• Subject requires primary treatment of one or more de novo or restenotic (treated with prior PTA) infrapopliteal lesions

• Subject must be at least 18 years of age

• Female subject of childbearing potential should not be pregnant and must be on birth control Note: Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

∙ Anatomic Inclusion Criteria:

• One or more native infrapopliteal lesions, including de novo lesions in the same limb. Restenotic (from prior PTA) lesions are allowed.

‣ Lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with vessel diameter of ≥ 2.5 mm and ≤ 4.00 mm by investigator visual assessment.

⁃ Total scaffold length to completely cover/treat target lesion(s) must be between 170 and 256 mm (maximum total everolimus drug dose of 2714 µg).

⁃ The target vessel can have any other angiographic significant lesions (≥50%) that should be treated per institution standard of care prior to treatment of the target lesion.

⁃ Tandem lesions are allowed and the total scaffold length used to cover the entire diseased segment must be ≤ 256 mm.

• Target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time of the procedure. If needed, quantitative imaging (angiography, IVUS, and/or OCT) can be used to aid accurate sizing of the vessels.

• The distal margin of the scaffold must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise. If the vessel segment distal to the target lesion has a significant lesion (\> 50% stenosis), it should be treated per institution standard of care prior to deployment of the scaffold.

• Significant lesion (≥ 50% stenosis) in the inflow artery(ies) must be treated successfully (as per physician's assessment of the angiography) through standard of care prior to the treatment of the target lesion. Treatment must be done within the same trial procedure. Treatment allowed for inflow artery lesions are PTA, atherectomy, cutting/scoring balloon, Shockwave balloon, bare metal stent, drug-eluting stents or drug-coated balloon. Everolimus-coated or eluting devices are not allowed.

• It is acceptable for non-target lesion(s) (if applicable) to be located in the same infrapopliteal vessel(s) as the target lesion, and suitable to be treated per institution standard of care. Non-target lesions must be treated successfully prior to target lesions and not requiring re-cross of the scaffold.

• Crossing of the target lesion in an antegrade fashion is preferred, but retrograde crossing may be used. However, the treatment must be delivered antegrade.