This study aims to demonstrate the safety and efficacy of the SELUTION SLRâ„¢ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject age is ≥ 18 years or minimum legal age as required by local regulations.
✓. Life expectancy \>1 year in opinion of investigator.
✓. Documented ischemia with Rutherford classification category 2, 3 or 4.
✓. Target lesion(s) in the SFA or PPA.
✓. Able to walk without the assistance of a walker.
✓. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
✓. Female subjects only: If female, then subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure and be prepared to use effective contraception for 12 months after treatment.
✓. Angiographic evidence that target lesion lies within the superficial femoral artery and/or proximal popliteal artery (P1 and P2 only).
Exclusion criteria
✕. 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.
✕. Inability to tolerate dual antiplatelet therapy.
✕. 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.
✕. Symptom onset less than 14 days prior to index procedure (acute limb ischemia).
✕. 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.
✕. Prior vascular surgery (including bypass and endarterectomy) of abdominal aorta, iliac arteries, or arteries of the index limb.
✕. Non-atherosclerotic disease of the index limb (including aneurysmal disease, vasculitis, Buerger's disease)