Revascularization of Total or Sub-total Occluded Peripheral Arterial Vessels With ByCross
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Freedom from device related serious adverse events
研究概览
简要总结
Post market clinical follow up of Bycross® device.
详细描述
A prospective, multi-center, non-randomized, observational, post market clinical follow-up study of the ByCross® device to evaluate the safety, technical performance and effectiveness of the ByCross® device and effectiveness of the procedure using the device and adjunctive therapy.
The ByCross® is a single use, disposable, minimal invasive aspiration rotational atherectomy device. The ByCross® is aimed to enable effective revascularization and restore blood flow in peripheral occluded vessels. In cases that the artery is completely blocked such that opening is not possible with currently available solutions and the procedure cannot be completed, the device is capable of crossing the blocked lesion without guiding wire and enables the completion of the procedure in a safe and effective manner, thus potentially eliminating the need for open bypass surgery. The ByCross® can be used in several pathologies: calcified atheroma, old and fresh thrombus and in stent restenosis at peripheral arteries including iliac
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has documented symptomatic chronic peripheral vascular disease at a vessel below the aorta bifurcation
- •Candidate for percutaneous intervention
- •Severely stenotic occlusion target vessel (stenosis ≥70%)
- •Subject has been informed on the nature of the study and has provided informed consent
- •Subject is capable of meeting study requirements including presences at follow-up visits
排除标准
- •Patient anatomy excludes use of BYCROSS® device
- •Vessels of the cardiopulmonary, coronary or cerebral circulations
- •Undersized vessel diameters (<3mm)
- •Perforation of the vessel distally or proximally to the occlusion segment prior atherectomy
- •Subintimal position of the guiding catheter or the guidewire
- •Use in stents or stent grafts if the guidewire has become threaded at any point in the wire mesh of stent or stent graft or the lining of the stent graft
- •Target is at vessel segment which includes tortuous course with radius of curvature <= 40mm
- •Access pathway includes tortuous course with radius of curvature <= 25mm, in specific extremely sharp aortic bifurcation
- •In aneurysmatically altered iliac vessel segments
- •If the introducer sheath, the guide catheter, the guidewire or the BYCROSS® sustains any visible damage, especially kinking
- •In the fracture areas of broken stents
- •Known or suspected allergy to any of the components of the system or to a medicinal product to be administered in connection with the planned procedure
- •Persistent vasospasm
- •During use of a defibrillator on the patient
结局指标
主要结局
Freedom from device related serious adverse events
时间窗: 90 days follow up
Freedom, at any period between procedure and 90 days post procedure from device related Serious Adverse Events (SADEs) defined by the site as part of the normal reporting practice
Acute procedure success
时间窗: Up to 8 hours post-procedure
Passage of the occlusion by the BYCROSS® device and post atherectomy residual stenosis ≤ 50% relative to reference diameter to allow for angioplasty and/or stenting if required, and complete procedural success of residual stenosis ≤ 30%
次要结局
- Rate of Target vessel revascularization (TVR) at 12 months(12 months)
- Rate of Target lesion revascularization (TLR) at 12 months(12 months)
- Rutherford classification improvement at 12 months(12 months)
- Rate of amputations of at 12 months(12 months)