Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries

Inclusion Criteria:

Pre-Operative Inclusion Criteria:

1. ≥18 years of age.

2. Rutherford Clinical Category 2-4.

3. Participant is willing to provide informed consent, is geographically stable, complywith the required follow up visits and testing schedule and recommended medicationregimen.

4. Women of childbearing potential who have a negative UPT at screening. Angiographical Inclusion Criteria:

5. One Lesion of ≥ 3 cm and ≤ 17 cm in length (if two discrete lesions are separated by ≤ 3 cm, but both falling within a composite length of ≤ 17 cm, they may be treatedas one lesion).

6. Lesion ≥70% stenosis by visual estimate.

7. Lesion location starts ≥1 cm below the common femoral bifurcation and terminatesabove the distal P2 segment (top of the tibial plateau).

8. De novo or non-stented restenotic lesion(s) in native femoropopliteal arteries >90days from prior interventional procedure.

9. Lesion is located at least 3 cm from any stent.

10. Target reference vessel diameter of 5-6 mm and able to be treated with availabledevice size matrix.

11. Successful, uncomplicated (without use of crossing device, specialty 035 guidewiresare acceptable) antegrade wire crossing of lesion.

12. Successful vessel preparation of the target lesion. Successful vessel preparation isdefined by successful pre-dilatation to nominal of the target lesion, in the absenceof early recoil, significant residual stenosis ≤30% as confirmed by angiographywithout any major vascular complications or flow-limiting dissections.

13. A patent inflow artery free from significant lesion stenosis (≥50% stenosis) asconfirmed by standard of care imaging and the discretion of the investigator Onlytreatment of ipsilateral iliac inflow arteries is acceptable before the treatment ofthe target lesion, defined as attainment of residual diameter stenosis ≤30% withoutdeath or major vascular complication.

14. At least one patent native outflow artery to the ankle, free from significant (≥50%)stenosis as confirmed by angiography, that has not previously been revascularized (outflow to be assessed after successful vessel preparation of target lesion;treatment of outflow disease is NOT permitted during the index procedure).

Exclusion Criteria:

Pre-Operative Exclusion Criteria:

1. ≥ 90 years of age.

2. Women who are breastfeeding, currently pregnant or planning to become pregnantduring the duration of the study or have a positive urine pregnancy test atscreening. Men who are intending to biologically father children during the durationof the study.

3. Life expectancy of <2 years

4. Participant has acute limb ischemia.

5. Previous treatment of the target limb using Drug Coated Balloon (DCB), a stent, orDrug Eluting Stent (DES) within the last 180 days.

6. Previous treatment of the contralateral limb using Drug Coated Balloon (DCB) or DrugEluting Stent (DES) within the last 90 days.

7. History of stroke or TIA within 90 days.

8. History of myocardial infarction (MI), thrombolysis or angina within 30 days ofindex procedure.

9. Renal failure (on dialysis) or chronic kidney disease (Glomerular Filtration Rate (GFR) < 30 ml/min per 1.73m2 (or serum creatinine ≥2.5 mg/L within 30 days of indexprocedure or treated with dialysis)) that in the opinion of the investigator shouldpreclude participant enrollment in the study.

10. Active or suspected active infection at time of index procedure that in the opinionof the investigator should preclude participant enrollment in the study.

11. Patients with any type of previous or planned surgical or interventional procedurewithin 30 days prior and/or within 30 days post-index procedure.

12. Sudden symptom onset (within two weeks), acute vessel occlusion, or acute orsub-acute thrombus in target vessel or history of treatment of thrombolysis in thetarget lesion.

13. Known contraindication (including allergic reaction) or sensitivity to sirolimus (rapamycin).

14. Known contraindication (including reaction) or sensitivity to iodinated contrastmedia, that cannot be adequately managed with pre- and post-procedure medication.CO2 angiography is not allowed.

15. Has received systemic immunosuppressants or immune-modifying drugs for >14 days intotal within 3 months prior to Screening (for corticosteroids ≥ 20 mg/day ofprednisone equivalent, excluding standard of care use of inhaled corticosteroids).

16. Immunosuppressive or immunodeficient state, in the opinion of the investigator, thatwould preclude the participant from being eligible to be treated with a sirolimusDCB. Note: HIV positive participants with CD4 count ≥350 cells/mm3 and anundetectable HIV viral load within the past year [low level variations from 50-500viral copies which do not lead to changes in antiretroviral therapy [ART] arepermitted.

17. Has active malignancy prior to study entry.

18. Bleeding diathesis, Gastrointestinal ulceration, another coagulopathy disorder, orallergy in the opinion of the investigator, which would restrict the use ofanticoagulant or dual antiplatelet therapy (DAPT).

19. Participant is currently participating in an investigational drug or device study,or previously enrolled in this study. Enrollment in another investigational drug ordevice study during the follow up period for this study is not allowed.

20. Current alcohol or drug abuse that in the opinion of the investigator shouldpreclude participant enrollment in the study.

21. Participant has a condition that in the opinion of the investigator should precludeparticipant enrollment in the study. Angiographical Exclusion Criteria:

22. Severe Calcification as defined as PARC scoring system (> 180 degrees (both sides ofthe vessel at the same location) and greater than one-half of the total lesionlength) of the target lesion.

23. Intended use of adjunctive primary treatment modalities (e.g., atherectomy, laser,cutting balloons, radiation therapy, stents, other drug coated devices.)

24. Use of reentry devices during the index procedure for antegrade recanalization,which include but are not limited to percutaneous intentional extraluminalrecanalization (PIER) and subintimal arterial flossing with antegrade retrogradeintervention (SAFARI) techniques.

Pharmacokinetic (PK) Sub-Study:

Inclusion Criteria:

1. Participant must meet all main study inclusion and exclusion criteria.

Exclusion Criteria:

1. Previous treatment or planned treatment with any Drug Coated Balloon (DCB) or DrugEluting Stent (DES) in the last 12 months and within 6 months post study indexprocedure.