DRKS00015758已完成2 期
Safety and effectiveness of ByCross Rotational and Aspiration device for revascularization of total or sub-total occluded peripheral arterial vessels of luminal diameter equal to or larger than 3mm: A prospective, multi-center study - ByCross Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Subject has documented symptomatic (Rutherford 2-6), chronic peripheral vascular disease requiring percutaneous intervention and are indicated for atherectomy at superficial femoral (SFA) and/or popliteal artery and/or tibioperoneal trunk (TPT).
- •2. Target lesion is at least 10mm distal to the SFA origin and at least 10mm proximal to the distal end of the TPT.
- •3. Total or sub-total occlusion of target vessel (stenosis =80%)
- •4. Vessel lumen =3.0mm
- •5. Lesion length =3.0cm
- •6. Subject has been informed on the nature of the study and is willing and able to provide informed consent
- •7. Subject is capable of meeting study requirements including presences at follow-up visits
排除标准
- •1. Subject is unable to take antiplatelet drugs
- •2. Vessel of the cardiopulmonary, coronary or cerebral circulation
- •3. Subject has anticipated life expectance < 12 month
- •4. Subject is diagnosed with impaired renal function (creatinine >2.5 mg/dL)
- •5. Subject has undergone or planned surgical or endovascular procedure 15 days before or after the study procedure
- •6. Vessel lumen <3.0mm
- •7. Stent at access and target vessel or In-stent restenosis at target lesion
- •8. Target and/or access vessel include by-pass graft
- •9. Target vessel is dissected
- •10. Target is at vessel segment which includes tortuous course with radius of curvature <= 40mm
- •11. Access pathway includes tortuous course with radius of curvature <= 25mm
- •12. Target and/or access vessel includes aneurysm altered segments
- •13. Persistent vasospasm
- •14. Known or suspected allergy to any of the components of the sys-tem or to a medicinal product to be administered in connection with the planned procedure
- •15. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
- •16. Subject is enrolled to another clinical investigation that might interfere with this study
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