Post-Market Clinical Follow-up Study with the ASPIREX®S Endovascular System to Assess the Safety and Effectiveness in the Treatment of DVT Patients and Special Patient Groups
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 9
- 主要终点
- Procedural success (removal of occlusion and restoration of blood flow)
研究概览
简要总结
The ASPIREX®S Endovascular System is a rotating and aspirating catheter system. It is intended to be used for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from native blood vessels (or vessels fitted with stents, stent grafts or native or artificial bypasses) outside the cardiopulmonary, coronary and cerebral circulations.
CAPTUREX® , a catheter with a filter basket, is intended to be used for the filtering of emboli from blood vessels during potentially embolizing procedures on the patient.
ASPIREX®S and CAPTUREX® are CE-marked (Class III) medical devices. In this study the effectiveness and safety in the removal of thrombi in veins is assessed under real life setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute thrombotic or thromboembolic occlusion (onset of pain < 14 days)
- •Age > 18 years
- •Written informed consent form
排除标准
- •Patient not suitable for thrombectomy
- •Fracture area 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
- •Severe coagulatory disorders
- •Patients with thrombophilia
- •Aneurysmatically altered vessel segments on target zone or on passage of catheter
- •Known or suspected infection, especially of the puncture site or the vessel segment being treated
- •Known, unhealed pre-existing mechanical damage to the vessel wall, especially caused by surgical procedures or interventional complications
- •Immature or not fully healed dialysis accesses or bypass grafts
- •Female subjects of childbearing capacity who are not willing to employ contraceptive measures
- •Pregnant or breast feeding subjects
- •Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this study or will not comply with requirements of the study
- •Subjects who are lawfully kept in an institution
- •Subjects who do not have the mental or physical ability to comply with time schedules and further study procedures
- •Current participation in any other clinical study (medicinal, medical device) or within the last 30 days prior to screening
结局指标
主要结局
Procedural success (removal of occlusion and restoration of blood flow)
时间窗: day of treatment
Primary patency
次要结局
- Hospital Stay(4-5 days after treatment)
- Adverse events(through study completion of 3 years)
- Adverse device effects(through study completion of 3 years)
- Technical success rate(intraoperative)
- Swelling of limb(through study completion of 3 years)
- Pain improvement(through study completion of 3 years)
- additional Treatment , acute(before 72 hours after treatment)
- additional Treatment, Long term(later than 72 hours after treatment)
- Time to return back to ward(day of treatment)