A Clinical Study Investigating the Safety and Efficacy of the URECA CTO Device
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- device success,
研究概览
简要总结
Clinical study to investigate the safety and the efficacy of the URECA CTO Device during recanalization and mechanical re-entry into the true lumen after passing the occlusions/calcifications (chronic total occlusions) in the peripheral vasculature.
详细描述
Peripheral Arterial Disease (PAD) restricts blood supply to the lower limbs. The disease causes obstructions that can affect blood vessels in both the proximal and distal regions. When these vessel obstructions exist for more than 3- 6 Months they are classed as chronic total occlusions. Without sufficient collateral formation this can lead to to chronic limb-treatening ischemia (CLTI), which is characterized by chronic pain and tissue loss. Without revascularization this frequently leads to amputation. The purpose of this clinical study is to investigate the safety and the efficacy of the URECA CTO Device during recanalization and mechanical re-entry into the true lumen after passing the occlusions/calcifications (chronic total occlusions) in the peripheral vasculature.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be >= 18 and <= 85 years old
- •Clinically diagnosed for endovascular treatment of peripheral vascular disease and chronic total occlusion in the iliac artery, superficial femoral artery or in the proximal popliteal artery determined by duplex, CTA, MRA and/or DSA.
- •Patient has been assessed by an independent vascular surgeon and an interventional radiologist.
- •Written and signed informed consent
排除标准
- •Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy;
- •Severe infection or soft tissue loss that may preclude any meaningful attempt at limb salvage;
- •Known or suspected allergies or contraindications to contrast agents;
- •Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study;
- •The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study;
- •Patient unable to give consent;
- •Pregnant and breastfeeding women;
- •Patients who recently suffered from a stroke and/or a myocardial infarct (Within 2 months)
- •Patients with an uncontrollable diabetes;
- •Severe intercurrent illness that, in the opinion of the investigator, may put the subject at risk when participating in the study
- •Patients with hypercoagulopathy;
- •Stent in place in the to be treated artery
结局指标
主要结局
device success,
时间窗: during surgery
the successful placement of a guidewire in the true lumen distal of the CTO using the URECA CTO Device without the occurrence of device related complications that involve a Serious Adverse Event.
safety of device
时间窗: 6 weeks after surgery
absence of device related Serious Adverse Events.
次要结局
- procedure time(during surgery)
- Total Fluoroscopy Time and(during surgery)
- Total Contrast Load(during surgery)
- Adverse Events(6 weeks after surgery)