• Subject (or their legally authorized representative) has provided written informed consent prior to any study-related procedure, using the form approved by the Institutional Review Board / Ethics Committee.

• Subject agrees not to participate in any other investigational device or drug study for a period of at least 12 months following the index procedure.

• Note: Questionnaire-based studies, or other studies that are non-invasive and do not require investigational devices or medications are allowed.

• Subject has symptomatic chronic limb-threatening ischemia, determined as Rutherford categories 4 or 5.

• Subject is ≥ 18 years of age.

• Subject agrees to complete all protocol-required follow-up visits, including angiograms.

• Angiographic Inclusion Criteria

• Target lesion(s) in the infrapopliteal vessel(s) of the same limb located in any of the following vessels: tibioperoneal trunk (TPT), anterior tibial artery (ATA), posterior tibial artery (PTA), or peroneal artery.

• Target lesion(s) must be located in the proximal 2/3 of the native infrapopliteal vessels and at least 10 cm above the tibio-talar joint.

• Note: Up to two (2) target lesions and two different arteries can be treated

• All target lesions must be successfully crossed with a guidewire prior to randomization.

• Note: For CTO, retrograde crossing of the lesion is allowed but treatment must be via antegrade.

• Note: The most distal lesion must be treated before treating more proximal lesions.

• Distal tibial and pedal runoff for each target lesion must be patent (free of lesions with \< 50% stenosis). If the index vessel is either anterior or posterior tibial artery, outflow must be contiguous with a patent dorsalis pedis or common plantar artery.

⁃ Inflow above-the-knee lesions must be treated successfully (\< 30% diameter stenosis by angiography without evidence of distal embolization, thrombus formation, or vessel rupture).

⁃ Note: Inflow lesions may be treated during the index procedure prior to target lesion(s) using the standard of care (including drug-eluting devices), without wiring the target lesion, if possible. Treatment of inflow lesions in the target limb within prior 30 days is also allowed provided the treatment was successful.

⁃ Note: Atherectomy of non-target lesions is not allowed.

⁃ Target lesion must have reference vessel diameter is between 2.75 - 3.75 mm by angiography. Vessel size measured by IVUS is highly recommended to verify RVD.

⁃ Target lesion(s) is de novo or restenosed ≥ 70% stenosed by angiography. Note: In-stent restenosis is an exclusion criterion.

⁃ The total target lesion length among all target lesions must not exceed 11 cm.

⁃ Minimum target lesion length must be \>14 mm.

⁃ Total scaffold length must not exceed 12 cm, and include at least 2 mm of normal vessel from each pre-dilatation border.

⁃ The target vessel must not have any other angiographic significant non-target lesions (≥ 50%).

⁃ Tandem non-contiguous target lesions are allowed if there is a plaque-free zone of ≥ 2 cm between the lesions. Total lesion lengths must not exceed 11 cm.

⁃ Target lesion(s) stenting does not block access to patent main named branches (tibioperoneal trunk (TPT), anterior tibial artery (ATA), posterior tibial artery (PTA), or peroneal artery).

⁃ Non-target below-the-knee lesions in non-target vessels must be successfully treated per standard of care prior to randomization without evidence of thrombosis, distal embolization, or vessel rupture.

⁃ Note: Drug-eluting and atherectomy devices for treatment of non-target lesions is not allowed.

⁃ Subject has suitable common femoral (contralateral or antegrade ipsilateral) vascular access.

⁃ Note: Retrograde pedal approach is allowed for crossing but not for treatment of target lesion(s).

⁃ At least one fully patent below-the-ankle artery (i.e., dorsalis pedis; common with either, lateral, or medial plantar arteries) without hemodynamically significant lesions (≥ 50% diameter stenosis by angiography) must be present in the target limb.