KAIZEN: Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 23
- 主要终点
- Percentage of Subjects With Acute Device Success
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •(≤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
研究组 & 干预措施
Peripheral Orbital Atherectomy System (OAS)
Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB)
干预措施: Peripheral Orbital Atherectomy System (OAS) (Device)
结局指标
主要结局
Percentage of Subjects With Acute Device Success
时间窗: At the end of the procedure
The percentage of subjects with the following, post-procedure: 1. ≤50% residual stenosis post OAD + POBA \[Angiographic Core Lab assessed\] and, 2. No OAS-related severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure \[CEC adjudicated\].
次要结局
- Change in Lesion Stenosis(Baseline, Post OAD, Post POBA)
- Acute Technical Success(At the end of the procedure)
- Drug Coated Balloon (DCB) Device Success(Within 3 minutes of insertion of DCB)
- Target Vessel Patency(Up to 6 months)
- Rate of Severe Angiographic Complications(At the end of the procedure)
- Change in Ankle Brachial Index (ABI)(Baseline (within 30 days of the clinical treatment), and Post Procedure (after the clinical trial treatment prior to discharge: post procedure ABI was collected on average 1.1 days post clinical trial treatment))
- Acute Procedural Success(72 hours after index procedure)
- Rate of Major Adverse Event (MAE)(30 days and 6 months)
- Change of Rutherford Classification (ITT Population)(Baseline, 30 days and 6 months)
- Change of Rutherford Classification (mITT Population)(Baseline, 30 days and 6 months)