Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization

Inclusion Criteria

• Age ≥ 18 years;
• Willing and able to provide informed consent.
• Ability to take at least one form of anti-platelet therapy.
• Rutherford categories 2 to 5 in the target limb.
• Lesions to be treated with the study device must be located in the same limb.
• Target lesion(s) located within the superficial femoral, popliteal or tibial arteries.
• Target lesion(s) with stenosis ≥70% diameter reduction as measured by site-reported angiography.
• Target lesion length(s) ≤150 mm.
• Target lesions(s) with reference vessel diameter (proximal and distal to target lesion) ≥2.0 mm and ≤4.0 mm.

Exclusion Criteria

• Subjects in whom amputation above the ankle is necessary, irrespective of the success of revascularization.
• In-stent restenosis within the target lesion.
• Flow-limiting dissection, Type C or greater.
• Target lesions within an autogenous or prosthetic bypass graft.
• History of an endovascular procedure or open vascular reconstruction in the index limb within the last 30 days, including thrombolytic therapy.
• Any open vascular surgical procedure planned in the target limb or endovascular procedures planned in the target vessel within 30 days after the index procedure.
• Kidney disease of sufficient severity, in the Investigator's opinion, to contraindicate lower extremity angiography using standard or alternate contrast agents as per the local Standard of Care.
• Pregnancy or breast feeding. A woman of child-bearing potential must have a negative pregnancy test within one week of index procedure.
• Myocardial infarction or stroke within 2 months of enrollment.
• Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy.
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count 1.5.
• Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pretreated in the opinion of the investigator.
• History of heparin-induced thrombocytopenia.
• Psychiatric disorder which, according to the investigator, has potential to interfere with provision of informed consent, completion of tests, therapy, or follow-up.
• Clinical/angiographic evidence of distal embolization or acute thrombus.
• Significant stenosis (>50% diameter reduction) or occlusion of inflow vessels that was not successfully treated (<50% residual stenosis without flow limiting dissection) before the study intervention.