NL-OMON55292已完成不适用
A clinical study investigating the safety, efficacy and performance of the URECA CTO device. - URECA
reca B.V.0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject must be ><= 18 and <<= 85 years old
- •2. Clinically diagnosed for endovascular treatment of peripheral vascular
- •disease and chronic total occlusion in the iliac artery, superficial femoral
- •artery or in the popliteal artery determined by duplex, CTA, MRA and/or DSA.
- •3. Patient has been assessed by an independent vascular surgeon and an
- •interventional radiologist
- •4. Written and signed informed consent.
排除标准
- •1. Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus,
- •coagulation disorder or receiving immunosuppressant therapy;
- •2. Severe infection or soft tissue loss that may preclude any meaningful
- •attempt at limb salvage;
- •3. Known or suspected allergies or contraindications to contrast agents;
- •4. Any significant medical condition which, in the investigator's opinion, may
- •interfere with the subject's optimal participation in the study;
- •5. 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;
- •6. Patient unable to give consent;
- •7. Pregnant and breastfeeding women;
- •8. Patients who recently suffered from a stroke and/or a myocardial infarct
- •(Within 2 months)
- •9. Patients with an uncontrollable diabetes;
- •10. Severe intercurrent illness that, in the opinion of the investigator, may
- •put the subject at risk when participating in the study
- •11. Patients with hypercoagulopathy;
- •12. Stent in place in the to be treated artery, unless stent is open, placed
- •more then 6 months before and can be safely passed in the investigator's
研究者
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