NCT04010123已完成不适用
Post-Market Clinical Follow Up of Rotarex®S Catheter
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 13
- 主要终点
- Freedom from major adverse events (MAE)
研究概览
简要总结
Post-Market Clinical Follow Up of the Rotarex®S Catheter
详细描述
A prospective, multi-center, non-randomized, multiple cohorts, observational, post market clinical follow-up study of the Rotarex®S Catheter to evaluate the safety, technical performance and medical efficacy of the Rotarex®S Catheter as a stand-alone and adjunctive therapy for the treatment of acute, subacute and chronic occlusions and sub-occlusions of arteries outside the cardiopulmonary, coronary and cerebral circulations, in accordance with Rotarex®S Catheter intended use.
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
- •Patient is ≥18 years old at the time of consent.
- •Subject has provided written informed consent prior to participation in the study, understands the purpose of this study and agrees to comply with all protocol-specified examinations and follow-up appointments.
- •Female patients of childbearing potential have negative pregnancy test ≤7 days before the procedure.
- •Documented symptomatic peripheral arterial disease.
- •Acute, subacute and chronic (sub-) occlusion, with ≥ 90% stenosis in native arteries and/or stents / stent grafts and/or Bypass grafts and/or AV Fistula (Dialysis access).
- •De novo or re-occluded lesion.
- •Vessel and/or stent diameter within treatable range as per Instruction For Use.
- •Occlusion crossed intraluminally by a guidewire.
- •For patients requiring lower limb intervention:
- •Patient presenting with a category from 2 to 5 according to the Rutherford classification for chronic limb ischemia or a category from I to IIb according to the Rutherford classification for acute limb ischemia.
排除标准
- •Life expectancy < 2 years.
- •Pregnant or nursing a child.
- •Contraindication, intolerance, or allergy to contrast media that, in the opinion of the investigator, cannot be adequately pre-medicated.
- •Myocardial infarction within 60 days prior to index procedure.
- •History of severe trauma and/or sepsis within 60 days prior to index procedure.
- •Cerebrovascular accident (CVA) or Transient Ischemic Attack (TIA) within 60 days prior to index procedure.
- •Evidence of intracranial or gastrointestinal bleeding or intracranial aneurysm within 90 days prior to index procedure.
- •Abnormal electrocardiogram or blood test results and/or any other factor that would increase risk by participating in the study in the opinion of the investigator.
- •Target lesion not crossed with guidewire or extraluminal guidewire crossing (even if in short segments only).
- •Additional lesion that is located >3cm away from the target lesion
- •Treatment plan of the target lesion includes laser, brachytherapy, or atherectomy other than the Rotarex®S Catheter.
- •Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
- •Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics.
- •Patients with uncorrected bleeding disorders.
- •Thrombophlebitis or deep vein thrombosis within the past 30 days.
结局指标
主要结局
Freedom from major adverse events (MAE)
时间窗: 30 days
Defined as clinically driven target lesion revascularization (TLR), any death and any unplanned major amputation of the index limb.
次要结局
- (MAE) Major adverse events Rate(6, 12 and 24 months)
- Technical success(Day 1)
- Incidence of Rotarex®S Catheter -related perforations.(From start to end of procedure)
- Freedom of Target Lesion Revascularization (TLR)(12 Months)
- Freedom of Target Vessel Revascularization (TVR)(1, 6, 12 and 24 Months)
- Incidence of clinically significant Rotarex®S Catheter -related distal embolization requiring further treatment with pharmacologic or mechanical devices (except treating with intravascular nipride or nitroglycerin).(From start to end of procedure)
- Clinical success(1, 6, 12 and 24 months)
- Hemodynamic success(30 days)
- Primary patency at 1, 6, 12 and 24 months.(1, 6, 12 and 24 months)
- Walking improvement at 1, 6, 12 and 24 months assessed by Vascu Quality of Life Questionnaire (VQ-6).(1, 6, 12 and 24 months)
- Quality of Life improvement at 1, 6, 12 and 24 months assessed by Questionnaire. (EQ5D-3L)(1, 6, 12 and 24 months)
- Duration of hospital stay for index procedure [days].(Duration of hospital stay, up to 12 weeks)
- Number of patients whose hemodialysis is efficient at 1, 6, 12 and 24 months without needing further treatment of the stenotic site after Rotarex®S treatment of the Arterio Venous-Fistula.(1, 6, 12 and 24 months)
- Duration of ICU stay for index procedure [days].(Duration of ICU stay, up to 12 weeks)
- Successful use of Arterio Venous-Fistula as dialysis access, defined as successful use of the fistula for dialysis on at least one occasion.(Up to 14 days)
- (ADEs) Adverse device effects Rate(6, 12 and 24 months)
- Procedural success(From start to end of procedure)
- (SAEs) Serious Adverse events Rate(6, 12 and 24 months)
- Procedure-related Adverse events Rate(6, 12 and 24 months)
研究者
研究点 (13)
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