Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

KAIZEN: Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified occlusive atherosclerotic lesion in the superficial femoral artery (SFA) and/or popliteal (POP) artery, which would be otherwise ineligible for endovascular therapy due to risk of complication. Study objective is to collect safety and effectiveness data to support potential commercialization of the peripheral OAS device in Japan.

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