NCT04663867已完成不适用
Safety and Effectiveness Study of the AngioSafe Peripheral CTO Crossing System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 18
- 主要终点
- Clinical Success of AngioSafe Peripheral CTO Crossing System
研究概览
简要总结
The study is designed to evaluate the safety and efficacy of the AngioSafe Peripheral CTO Crossing System.
详细描述
The purpose of the study is to demonstrate the safety and effectiveness of the AngioSafe Peripheral CTO Crossing System. The system facilitates the crossing of chronic total occlusions (CTOs) in the peripheral arteries of lower limbs. A minimum of 70 subjects will be treated across selected study enters within the U.S. and followed for 30 days.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to comply with protocol requirements and sign informed consent form
- •≥ 22 years of age
- •Peripheral arterial disease defined by Rutherford Clinical Classification (Category 2-5)
- •Peripheral artery disease in target extremity is confirmed by imaging (catheter angiography, computed tomographic angiography (CTA), and/or magnetic resonance angiography (MRA))
- •Angiographic Inclusion Criteria:
- •Target lesion in native de novo common femoral artery (CFA), superficial femoral artery (SFA), and/or popliteal artery
- •Vessel diameter(s) for target lesion is ≥ 3.0mm and ≤ 10mm
- •Subject's target lesion is a severely stenosed segment of ≤ 300 mm that involves the CTO(s)
- •Subject's target lesion involves at least one CTO that is 99-100% stenosed
- •Subject has at least one vessel with run-off to the foot
排除标准
- •Systemic infection or an infection in extremity of target lesion
- •Target lesion within native vein or synthetic vessel grafts or in stent occlusion
- •Planned intervention in the contralateral limb during the study
- •Planned intervention in the target limb of the inflow vessels during the study
- •Planned intervention of lower extremities after study procedure within 30-day follow-up visit
- •Coagulopathy or bleeding diatheses, thrombocytopenia with platelet count less than 50,000/μl, or INR > 1.7
- •Antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated
- •Allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated
- •Allergy to nickel, titanium, urethane, nylon, or silicone
- •History of myocardial infarction within 30 days prior to enrollment/consent
- •History of stroke within 30 days prior to enrollment/consent
- •Chronic kidney disease (CKD) of stage 4 or greater based on an Estimated Glomerular Filtration Rate (eGFR) <30ml/Min, unless the subject is on chronic renal replacement therapy
- •Hemoglobin levels <10g/dL verified by a lab test no older than 14 days prior to enrollment, unless the subject has a history of chronic anemia at a stable level, no recent bleeding diathesis or history of blood transfusion in the last six weeks
- •Pregnant or nursing, for females of child-bearing potential (< 50 years of age)
- •Participating in another interventional research study that may interfere with study endpoints
- •Prior major amputation (above ankle) in target extremity
- •Acute limb ischemia (ALI)
- •Prior unsuccessful attempt to cross the target lesion
- •Subject has had a procedure on the target limb or contralateral limb within 7 days
- •Subject has had a procedure on the target limb or contralateral limb within the past 30 days and is unstable
研究组 & 干预措施
AngioSafe Peripheral CTO Crossing System Procedure
Experimental
Use of AngioSafe Peripheral CTO Crossing System to facilitate the intraluminal placement of guidewires beyond Chronic Total Occlusions (CTOs) in the peripheral vasculature.
干预措施: AngioSafe Peripheral CTO Crossing System (Device)
结局指标
主要结局
Clinical Success of AngioSafe Peripheral CTO Crossing System
时间窗: 24 Hours
Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner.
次要结局
- Evaluation of Intraluminal CTO Crossing Facilitated by the Peripheral CTO Crossing System, as Assessed by an Intravascular Ultrasound (IVUS).(Procedure, evaluated directly after performing the investigational procedure)
- Procedural Success of AngioSafe Peripheral CTO Crossing System(30 Days)
- Technical Success of AngioSafe Peripheral CTO Crossing System(Procedure, evaluated directly after performing the investigational procedure)
- The Primary Endpoint (Clinical Success) in the Subgroups by the Degree of Calcification (None/Focal/Mild, and Moderate/Severe).(24-hours)
研究者
研究点 (18)
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