SELUTION4SFA: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Efficacy of the SELUTION SLR 018 Drug Eluting Balloon in the Treatment of Subjects with Femoro popliteal Artery Lesions

The purpose of this study is to learn how safe and effective the SELUTION Sustained Limus Release (SLR)™ Drug-Eluting Balloon (DEB) is in treating patients with peripheral arterial disease (PAD). Potential subjects in this study have a narrowing of the artery in their upper leg.

In patients with PAD, blood vessels in the leg can sometimes narrow or close off, which limits the amount of blood flow in their leg and foot. When patients have narrowing of their blood vessels, doctors can insert a small balloon into the blood vessel and then inflate the balloon in the narrowed region to help open up the blood vessel and restore proper blood flow. Balloon catheter or balloon angioplasty procedures are routinely performed and are not experimental.

If you decide to take part in this research study, you will have screening tests and assessments performed to make sure you should be enrolled in the study. If you meet criteria to participate, you will have a procedure performed and be treated with the SELUTION drug-eluting balloon (study device) or a standard, non-experimental balloon. You will then have follow-up tests and assessments performed at approximately 1-month, 6-months, 1-year, 2-years, 3-years, 4-years, and 5-years following your procedure.

Eligibility:

Subjects must meet all of the following criteria to participate in the trial:

1. Subject age is ≥ 18 years or minimum legal age as required by local regulations.

2. Subject life expectancy >1 year in opinion of investigator.

3. Subject has documented ischemia with Rutherford classification category 2, 3 or 4 and symptoms of > 2 weeks duration.

4. Able to walk without the assistance of a walker.

5. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.

6. Female subjects only: If female, then subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.

Exclusion:

Subject will be excluded if any of the following criteria apply:

1. Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned for within 30 days following index procedure, with exception for diagnostic angiography.
2. Inability to tolerate dual antiplatelet therapy.
3. Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents, such as contrast agent, which are required for the procedure and which cannot be adequately pre-treated.
4. Stroke or MI within 3 months of enrollment.
5. Symptom onset less than 14 days prior to index procedure (acute limb ischemia).
6. Lower limb disease in the contralateral leg that requires treatment at the index procedure, or, that is planned within 14 days prior to the index procedure or within 30 days after the index procedure.
7. Prior vascular surgery (including bypass and endarterectomy) of abdominal aorta, iliac arteries, or arteries of the index limb.
8. Non-atherosclerotic disease of the index limb (including aneurysmal disease, vasculitis, Buerger's disease)
9. Target lesion requires treatment with alternative therapies such as thrombolysis, thrombus aspiration, cutting/scoring/contoured balloon, stenting, laser, cryoplasty, intravascular lithotripsy, brachytherapy, re-entry device).
10. Subject has target lesion(s) that require treatment via pedal site.
11. Subject has target lesion(s) that require access via upper extremity arteries.
12. Hypercoagulable state or disorder present, or coagulopathy present, including platelet count less than 80,000 per microliter.
13. Chronic renal insufficiency (dialysis dependent, or serum creatinine >2.5 mg/dL within 30 days of index procedure).
14. Systemic infection (WBC > 12,000 and febrile) or known immune compromise.
15. Breast-feeding woman.
16. Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.