A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System for the TREatment of Vascular Lesions Located in the InfrapoplitEal Arteries BeLow the Knee (DEEPER REVEAL)

Pre-Procedure Inclusion Criteria:

1. Subject willing and able to provide informed consent and able to comply with thestudy protocol and follow up. Subjects who are unable to sign due to a physicallimitation may have a witness, including a family member, sign on their behalf.

2. Life expectancy greater than 1 year in the investigator's opinion.

3. Male or non-pregnant female ≥18 years of age at time of consent.

4. Subjects must have chronic (greater than 14 days) symptoms of limb ischemia,determined by clinical symptoms of Rutherford class 4-5, rest pain (R 4), and/orminor tissue loss (R5), that in the opinion of the investigator are not amenable toconservative medical therapy and require endovascular intervention for alleviationof symptoms and tissue preservation.

5. For subjects with bilateral disease, planned treatment of the contralateral limbmust either be performed greater than or equal to 3 days prior to the indexprocedure or greater than or equal to 7 days following the index procedure.

Angiographic Inclusion Criteria:

1. Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels,with target lesion that can be successfully crossed via the true lumen with aguidewire (no subintimal crossing).

2. Iliac, SFA and popliteal inflow lesions can be treated using standard of care duringthe index procedure or greater than or equal to 3 days prior. Note:

3. Inflow lesions treated intraprocedure must be treated first, prior toconsideration of treatment of infrapopliteal lesions.

4. Treatment of in-stent restenosis in inflow treatment is permitted, providedthat stents are not fractured or otherwise compromised.

5. Distal embolic protection is strongly encouraged in cases where atherectomy isused.

6. Inflow lesions must have a healthy vessel segment of greater than 30 mm betweenthe study lesion and the treated segment, defined as less than 50% stenosiswithout aneurysmal segments.

7. Inflow treatment must be successful, prior to treatment of the target lesion,resulting in stenosis less than or equal to 30%, without resulting flowlimiting dissection, thrombus, or aneurysm by angiography.

8. Target vessel(s) reconstitute(s) at or above the ankle, with the target treatedsegment ending at least 10 mm above the ankle joint. Note:

9. If the anterior tibial or posterior tibial arteries are treated, there must beinline flow to the foot.

10. If the peroneal artery is treated, there must be at least one collateralsupplying the foot.

11. In all cases, patent runoff (no lesions with greater than 50% stenosis) must bepresent via the dorsalis pedis and/or plantar arteries

12. Target lesion must be located in the tibial arteries. If vessel sizing remainsappropriate, treatment may extend into the distal popliteal (P3) segment.

13. Target vessel reference diameter is measured to be between 2.5 to 4.5 mm in diameterassessed by one of the following methods after successful completion of guidewirecrossing of the lesion site:

14. Intravascular Ultrasound (IVUS) (primary)

15. Visual estimate using Angiography (secondary)

16. Target lesion length is less than or equal to 210mm in length. Tandem lesions thatare less than or equal to 4 cm should be treated as one lesion. Multiple discretelesions may be treated provided cumulative length is less than or equal to 210 mm.

17. Successful pre-dilatation of the target lesion defined as resulting in stenosis lessthan or equal to 50% and/or inner lumen diameter greater than or equal to 2.0 mm indiameter, without resulting flow limiting dissection, thrombus, or aneurysm byangiography prior to the insertion of the Bare Temporary Spur Stent System.

18. Only one limb and one contiguous vessel may be enrolled per subject. If required, asecond modality may be used for treatment in the non-target infrapopliteal vessel. Note:

19. Distal embolic protection is strongly recommended in cases using atherectomy.

20. Treatment of the target vessel/lesion may be performed only if treatment of thenon-target lesion is successful without resulting flow limiting (Type D orgreater) dissection, thrombus, or aneurysm by angiography.

21. Treatment of non-target lesions must be parallel to, and not contiguous with,the target lesion.

22. If pre-screening with duplex ultrasound, angiography, CTA, or MRA has been performedless than or equal to 365 days prior to the procedure, intra-procedure angiographyof the aorto-iliac vasculature is not required, however, the femoropopliteal inflowmust still be imaged using angiography during the index procedure.

23. Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing;however, the Bare Temporary Spur Stent System must be deployed from antegrade (abovethe knee, either ipsilateral or contralateral) access.

Pre-procedure Exclusion Criteria:

1. Subject unwilling or unlikely to comply with the 1-year duration of the study in theopinion of the investigator.

2. Subject is pregnant or planning to become pregnant during the course of the trial.

3. Subject has an active systemic infection that is not controlled at the time of theprocedure, including septicemia or bacteremia.

4. Subject has osteomyelitis proximal to the phalanges. Osteomyelitis in the digit(s)of the target foot is permitted.

5. Wounds must be confined to the foot below the ankle. Heel wounds are excluded.

6. Planned major (above the ankle) amputation of the target limb. A planned or previousminor (trans metatarsal amputation or digit amputation) is permitted.

7. Recent myocardial infarction or stroke less than 90 days prior to the indexprocedure.

8. Symptomatic acute heart failure NYHA class III or greater.

9. Impaired renal function (eGFR less than or equal to 25 mL/min) within 30 days ofprocedure or end stage renal disease on dialysis.

10. Inability to tolerate dual antiplatelet and/or anticoagulation therapy.

11. Known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulanttherapies which could not be substituted, or an allergy to contrast media thatcannot be adequately pre-treated prior to the index procedure.

12. The subject is currently enrolled in another investigational device or drug trialthat interferes with the study endpoints.

13. Known allergy to nitinol or nickel.

14. Bypass surgery of the target vessel(s). Prior bypass above the level of theinfrapopliteal arteries is permitted.

Angiographic Exclusion Criteria

1. Target lesion is located within an aneurysm or associated with an aneurysm in thevessel segment either proximal or distal to the target lesion. Inflow must also befree of aneurysmal segments.

2. Fractured or otherwise compromised stents in the target vessel or inflow vessel.

3. In-stent restenosis in the target vessel.

4. Previous treatment of inflow lesions performed less than or equal to 7 days prior tothe index procedure.

5. Previous treatment of the target vessel less than or equal to 90 days prior to indexprocedure.

6. Angiographic evidence of thrombus within target limb.

7. Extremely severe calcification that, in the investigator's opinion, would not beamenable to PTA.

8. Type D dissections or greater incurred during CTO crossing (see Appendix I fordefinitions).

9. Significant (greater than or equal to 50%) stenosis of inflow arteries orunsuccessful treatment of inflow lesions.

10. Distance from access to lesion is too long for a 135 cm working length of the BareTemporary Spur Stent System catheter.