Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

Other criteria

• General Inclusion Criteria (≤30 Days from Clinical Trial Treatment):
• 18 years of age or older
• Subject has signed the approved KAIZEN study Informed Consent Form prior to any study-related procedures
• Chronic, symptomatic lower limb ischemia
• Clinical indication for percutaneous transluminal angioplasty intervention in the native SFA and/or POP artery; General Exclusion Criteria (≤30 Days from Clinical Trial Treatment):
• Female who is pregnant and/or breastfeeding
• Currently participating in another investigational clinical study
• Unwilling to follow the Investigator's instructions or follow-up requirements
• Any non-diagnostic peripheral vascular intervention that was unsuccessful or had complications within 30 days before clinical trial treatment
• Any non-diagnostic coronary intervention within 30 days before clinical trial treatment
• Any planned non-diagnostic vascular intervention(s) within 30 days after clinical trial treatment
• Any planned procedures or other medical conditions which, in the Investigator's opinion, may interfere with the study result and/or subject's optimal participation in the study
• Prior major amputation within one year of the clinical trial treatment procedure
• Planned major amputation
• Life expectancy of ≤6 months
• History of coagulopathy or hypercoagulable bleeding disorder
• History of Myocardial Infarction (MI), or stroke/cerebrovascular accident within 6-months prior to the clinical trial treatment
• Unstable angina pectoris
• Untreatable hemorrhagic disease or platelet count <80,000mm3 or >600,000mm3
• Evidence of active infection
• Known hypersensitivity or contraindication to contrast dye
• Known hypersensitivity/allergy to the investigational atherectomy system or protocol-related therapies
• Known contraindication to antiplatelet therapy
• Creatinine > 2.5 mg/dL, unless on dialysis; Clinical Trial Treatment Inclusion:
• De novo target lesion
• All guidewires cross the target lesion within the true lumen
• Target lesion with ≥70% stenosis
• Target reference vessel diameter (RVD) ≥3.0 mm and ≤6.0 mm
• Target lesion length ≤150 mm
• Minimum one patent tibial vessel on the target leg
• Target lesion has visual evidence of calcification; Clinical Trial Treatment Exclusion:
• Any inflow treatment that was unsuccessful or had complications during the clinical trial treatment, prior to subject enrollment
• Target lesion is a chronic total occlusion
• Presence of any other lesions in the target limb requiring a planned surgical intervention or endovascular procedure 30-days after clinical trial treatment
• Presence of aneurysm in the target vessel
• Acute ischemia and/or acute thrombosis of the SFA and/or POP artery
• Angiographic evidence of perforation
• Angiographic evidence of severe dissection
• Planned use of atherectomy other than Cardiovascular Systems, Inc. (CSI) Peripheral OAS in the target limb