SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries

Inclusion criteria

• Patient is ≥18 years
• Patient has Rutherford Classification 2,3 or4.
• Patient has provided written informed consent and is willing to comply with studyfollow-up requirements.
• De novo stenotic or occlusive lesion(s) or non-stented restenotic or occlusivelesion(s) occurring >90 days after prior plain old balloon (POBA) angioplasty or >180days after prior DCB treatment.
• Target lesion is located between the ostium of the SFA and the end of the P1 segmentof the popliteal artery
• Target vessel diameter ≥ 4 mm and ≤ 7 mm
• Target lesion must be stenotic or occlusive lesion ≤ 150mm in length (one long lesionor tandem lesions) by investigator's visual estimate. [Note: tandem lesions must havea total length of ≤ 150 mm by visual estimate and be separated by ≤ 30 mm.]
• Target lesion must have angiographic evidence of ≥ 70 % stenosis by investigator'svisual estimation
• Successful, uncomplicated crossing of the target lesion occurs when the tip of theguidewire is distal to the target lesion without the occurrence of flow-limitingdissection of perforation and is judged by visual inspection to be within the truelumen. Subintimal dissection techniques may be used if re-entry occurs above-the-knee (ATK) and without the use of re-entry devices.
• Target lesion is located at least 30mm from any stent if target vessel was previouslystented.
• A patent inflow artery free from significant stenosis ((≥50% stenosis) as confirmed byangiography.
• At least one patent native outflow artery to the ankle or foot, free from significantstenosis (≥ 50 % stenosis) as confirmed by angiography.

Exclusion criteria:

• Acute Limb Ischemia
• Patient underwent an intervention involving the target vessel within the previous 90days.
• Patient underwent any lower extremity percutaneous treatment in the ipsilateral limbusing plain old balloon (POBA) angioplasty within the previous 90 days.
• Patient underwent a percutaneous transluminal angioplasty (PTA) of the target lesionusing a DCB within the previous 180 days.
• Pregnant women or women who are intending to become pregnant.
• Patient has a life expectancy of less than 1 year
• Patient has a known allergy to contrast medium that cannot be adequatelypre-medicated.
• Patient is allergic to all anti-platelet treatments
• Patient is receiving immunosuppressant therapy
• Patient has platelet count <100.000/mm3 or >700.000/mm
• Patient has history of gastrointestinal hemorrhage requiring a transfusion within 3months prior to the study procedure
• Patient is diagnosed with coagulopathy that precludes treatment with systemicanticoagulation and/or dual antiplatelet therapy (DAPT)
• Patient has history of stroke within past 90 days
• Patient has history of myocardial infarction within the past 30 days.
• Patient is participating in an investigational drug or medical device study that hasnot completed primary endpoint(s) evaluation or that clinically interferes with theendpoints from this study.
• Patient has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure orintervention unrelated to this study within 30 days prior to the index procedure orhas planned major surgical procedure or intervention within 30 days of the indexprocedure
• An intervention in the contralateral limb, planned within 30 days post-index procedure
• Patient had previous bypass surgery of the target lesion
• Patient had previous treatment of the target vessel with thrombolysis or surgery
• Patient is unwilling or unable to comply with procedures specified in the protocol orhas difficulty or inability to return for follow-up visits as specified by theprotocol
• Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5 mm)
• Target Lesion requires treatment with alternative therapy such as stenting, laser,atherectomy, cryoplasty, brachytherapy or re-entry devices
• Significant target vessel tortuosity or other parameters prohibiting access to thetarget lesion
• Presence of thrombus in the target vessel
• Iliac inflow disease requiring treatment, unless the iliac artery disease issuccessfully treated first during the index procedure. Success is defined as ≤ 30 %residual diameter stenosis without death or major complications.
• Presence of an aortic, iliac or femoral artificial graft.