Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

Inclusion Criteria:

• Subject is ≥18 years.

• Subject has target limb Rutherford classification 2, 3 or 4.

• Subject has provided written informed consent and is willing to comply with studyfollow-up requirements.

• De novo lesion(s) or non-stented restenotic lesion(s) occurring >90 days after priorplain old balloon (POBA) angioplasty or >180 days after prior DCB treatment.

• Target lesion location starts ≥10 mm below the common femoral bifurcation andterminates distally at or above the end of the P1 segment of the popliteal artery.

• Target vessel diameter ≥4 mm and ≤7 mm.

• Target lesion must have angiographic evidence of ≥70% stenosis by operator visualestimate.

• Chronic total occlusions may be included only after successful, uncomplicated wirecrossing of target lesion via an anterograde approach and without the use ofsubintimal dissection techniques.

• Target lesion must be ≤180 mm in length (one long lesion or multiple serial lesions)by operator visual estimate. Note: combination lesions must have a total lesionlength of ≤180 mm by visual estimate and be separated by ≤30 mm.

• Target lesion is located at least 30 mm from any stent, if target vessel waspreviously stented.

• Successful, uncomplicated (without use of a crossing device) wire crossing of targetlesion. Successful crossing of the target lesion occurs when the tip of the guidewire is distal to the target lesion without the occurrence of flow-limitingdissection or perforation and is judged by visual inspection to be within the truelumen.

• After pre-dilatation, the target lesion is ≤70% residual stenosis, absence of a flowlimiting dissection and treatable with available device matrix.

• A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmedby angiography.

• At least one patent native outflow artery to the ankle or foot, free fromsignificant stenosis (≥50% stenosis) as confirmed by angiography.

Exclusion Criteria:

• Subject has acute limb ischemia.

• Subject underwent percutaneous transluminal angioplasty (PTA) of the target limbusing plain old balloon angioplasty (POBA) or a stent within the previous 90 days.

• Subject underwent any lower extremity percutaneous treatment using apaclitaxel-eluting stent or a DCB within the previous 90 days.

• Subject underwent PTA of the target lesion using a DCB within the previous 180 days.

• Subject has had prior vascular intervention in the contralateral limb within 14 daysbefore the planned study index procedure or subject has planned vascularintervention in the contralateral limb within 30 days after the index procedure.

• Subject is pregnant, breast-feeding or intends to become pregnant during the time ofthe study.

• Subject has life expectancy less than 2 years.

• Subject has a known allergy to contrast medium that cannot be adequatelypre-medicated.

• Subject is allergic to ALL antiplatelet treatments.

• Subject has impaired renal function (i.e. serum creatinine level ≥2.5 mg/dL).

• Subject is dialysis dependent.

• Subject is receiving immunosuppressant therapy.

• Subject has known or suspected active infection at the time of the index procedure.

• Subject has platelet count <100,000/mm3 or >700,000/mm3.

• Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3months prior to the study procedure.

• Subject is diagnosed with coagulopathy that precludes treatment with systemicanticoagulation and/or dual antiplatelet therapy (DAPT).

• Subject has history of stroke within the past 90 days.

• Subject has a history of myocardial infarction within the past 30 days.

• Subject is unable to tolerate blood transfusions because of religious beliefs orother reasons.

• Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol.

• Subject is participating in another investigational drug or medical device studythat has not completed primary endpoint(s) evaluation or that clinically interfereswith the endpoints from this study, or subject is planning to participate in suchstudies prior to the completion of this study.

• Subject has had any major (e.g. cardiac, peripheral, abdominal) surgical procedureor intervention unrelated to this study within 30 days prior to the index procedureor has planned major surgical procedure or intervention within 30 days of the indexprocedure.

• Subject had previous bypass surgery of the target lesion.

• Subject had previous treatment of the target vessel with thrombolysis or surgery.

• Subject is unwilling or unable to comply with procedures specified in the protocolor has difficulty or inability to return for follow-up visits as specified by theprotocol.

• Target lesion has severe calcification (as defined by the PARC classification ofcalcification).

• 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, re-entry devices, or subintimal dissectiontechniques.

• 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.