A Non-RanDomized Pilot Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base Drug-coated Balloon (DEEPER LIMUS)

• Subject is willing and able to provide informed consent and able to comply with the study protocol.

• Life expectancy \>1 year in the investigator's opinion.

• Subject is \> 18 years of age.

• Subjects must have symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 3-5, including severe, life-limiting claudication (R 3), rest pain (R 4), and/or minor tissue loss (R5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation

• Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed with a guidewire.

• Target lesion must meet lesion-specific criteria in pre-screening by angiography at time of procedure (prescreening with CTA, MRA or selective angiography may be performed prior to the index procedure).

• Target vessel(s) reconstitute(s) at or above the ankle, with the target treated segment extending no more than 10 mm beyond the ankle.

• Note:

• If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot.

• If the peroneal artery is treated, there must be at least one collateral supplying the foot.

• Target lesion must begin no higher than the tibial trifurcation (popliteal artery excluded).

• Target vessel reference diameter is measured to be between 2.0 mm to 4.5 mm in diameter, assessed by one of the following methods after successful completion of guidewire crossing of the lesion site:

∙ Intravascular Ultrasound (IVUS)

‣ Optical Coherence Tomography (OCT)

‣ Quantitative Vascular Angiography (QVA)

⁃ Lesion length must be \> 30 mm and \< 200 mm.

⁃ Only one limb may be enrolled per subject. Up to two vessels may be treated per subject; if required, a second modality may be used for treatment in the non-target infrapopliteal vessel. Any treatment of the non-index vessel must be performed prior to the use of the investigative device and only one artery may be treated with the investigative device

⁃ The treated segment is defined as the total length of artery treated with the investigational device. Target treatment length is \<250 mm with a maximum segment of 200 mm separated by 30 mm of healthy tissue between treated lesions.

⁃ Successful pre-dilatation of the target lesion as outlined in the procedure instructions, defined as resulting in stenosis \<50%, without resulting flow limiting (Type D or greater) dissection, thrombus, or aneurysm by angiography prior to the insertion of the investigative device.

⁃ Iliac, SFA and popliteal inflow lesions can be treated using standard angioplasty and/or drug coated balloon and/or an approved stent (no atherectomy) during the index procedure or \>30 days prior. Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions. If pre-screening with duplex ultrasound, angiography, CTA, or MRA has been performed \< 365 days prior to the procedure, intra-procedure angiography of the aorto-iliac vasculature is not required, however, the femoropopliteal inflow must still be imaged using angiography during the index procedure. Inflow lesions must have a healthy vessel segment of \>30 mm between the study lesion and the treated segment, defined as less than 50% stenosis without aneurysmal segments.

⁃ Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing, however, the Temporary Spur Stent System must be deployed from antegrade access.

⁃ For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed \>30 days prior to the index procedure or \> 14 days following the index procedure.