Feasibility Clinical Trial of the Cardio Flow FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Number of Treated Lesions With Achievement of ≤ 50% Residual Stenosis Without Adjunctive Therapy
研究概览
简要总结
This trial is a First in Human early feasibility study of a novel atherectomy device to treat peripheral artery disease. The trial is a prospective, single arm design that will enroll 10 patients at 1 - 2 sites. Patients will be followed at 30 days and 6 months to evaluate vessel patency following treatment. Safety will be assessed by monitoring adverse events throughout the study. Safety and Efficacy will be evaluated by comparing study results to established performance criteria,
详细描述
Feasibility Clinical Trial of the Cardio Flow FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease (FAST Trial) is a prospective non-randomized single arm study that will enroll up to 10 patients at 1 - 2 sites. The study will evaluate the safety and effectiveness of the Cardio Flow atherectomy device for plaque removal in de novo target lesions in the peripheral vasculature of the lower extremities. The primary safety endpoint is defined as freedom from a composite of new onset major adverse events through the 30-day follow-up as adjudicated by an independent Clinical Events physician. The primary effectiveness endpoint is defined as the ability of the Cardio Flow Device to achieve a residual diameter stenosis ≤ 50% without adjunctive therapy, determined by Angiographic core lab evaluation.
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
- •Candidate for percutaneous endovascular intervention in the lower extremity;
- •Disease is located in peripheral arteries between 2mm and 5mm diameter;
- •Ankle brachial index ≤ 0.90;
- •Rutherford classification 2,3,4 or 5;
- •De novo target lesion has ≥ 50% stenosis;
- •Target lesion length ≤ 200 cm;
- •At least 1 patent tibial vessel runoff;
- •Written, signed informed consent.
排除标准
- •Female not using adequate contraception or is breastfeeding;
- •Rutherford class 0 1, and 6;
- •target lesion within a native graft,
- •in-stent restenosis,
- •≤ 50% occlusion, or chronic total occlusion;
- •history of vascular surgery or interventional procedure on index limb within 30 days prior to procedure, or planned procedure within 30 days after index procedure, lesion in contralateral limb requiring intervention during index procedure or within 30 days of index procedure;
- •known or suspected systemic infection;
- •unstable coronary disease; significant kidney disease requiring dialysis;
- •evidence of aneurysmal target vessel within past 2 months;
- •evidence of intracranial or GI bleeding, intracranial aneurysm, MI or stroke within 2 months of baseline evaluation;
- •history of heparin-induced thrombocytopenia;
- •contraindication to anti-platelet, anticoagulant, or thrombolytic therapy;
- •uncorrected bleeding disorders;
- •thrombolytic therapy within 2 weeks of index procedure;
- •life expectancy less than 12 months;
- •unwilling or unable to comply with follow-up requirements;
- •intraoperative complications due to the use of a marketed device prior to use of the atherectomy system;
- •currently participating in an investigational drug or other device study that has not completed primary endpoint;
- •unable to tolerate standard interventional procedures if the study device is not effective.
结局指标
主要结局
Number of Treated Lesions With Achievement of ≤ 50% Residual Stenosis Without Adjunctive Therapy
时间窗: At time of procedure
Achievement of ≤ 50% residual stenosis without adjunctive therapy as assessed angiographically on a per lesion basis
Number of Participants Who Were Free From New-onset Major Adverse Events at 30 Days Post-treatment
时间窗: 30 days
Major adverse events include the following: * All cause cardiovascular mortality. * Myocardial infarction (MI): Any newly diagnosed MI post procedure, defined as CK-MB ≥2X upper limit normal (ULN). * Clinically driven target lesion revascularization (TLR): any repeat percutaneous or surgical intervention to treat objectively documented symptoms of recurrent ischemia attributable to the treated lesion. * Clinically significant target vessel dissection: NHLBI grade C or greater as confirmed by angiography. * Clinically significant target vessel perforation: NHLBI Type III as confirmed by angiography. * Unplanned major target limb amputation: Amputation at the level of the trans-metatarsals or higher that was not previously planned * Clinically relevant distal embolization: Emboli requiring surgical or medical intervention and/or the presence of symptoms. * Pseudoaneurysm: disruption of the arterial wall at the treatment site as confirmed by angiography.
次要结局
- Number of Lesions With Achievement of ≤ 50% Residual Stenosis With or Without Adjunctive Low-pressure Balloon Therapy(At time of procedure)
- Serious Adverse Events(Through six months)