Safety and Efficacy of the Drug Eluting Balloon (DEB) for the Treatment of the Superficial Femoral Artery (SFA) Ischemic Vascular Disease in Symptomatic Patients Presenting With Long Lesions: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 6
- 主要终点
- rate of primary patency
研究概览
简要总结
The primary purpose of this study is to assess safety and efficacy of the Drug Eluting Balloon (DEB) technology for the treatment of the Superficial Femoral Artery (SFA) ischemic obstructive vascular disease in patients presenting with long lesions. As secondary aim this study is going to explore treatment effect on a number of procedural and clinical endpoints in order to collect information to design a future comparative effectiveness study.
详细描述
The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Eluting Balloon (DEB) technology for the treatment of symptomatic Superficial Femoral Artery (SFA) ischemic vascular disease in patients presenting with long lesions.
The present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (CE marked) DEB currently available on the market.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to Rutherford Category 2, 3 or 4;
- •Target lesion consists of a single solitary or multiple adjacent de novo or restenotic lesions (non-in-stent) with diameter stenosis ≥ 70% by visual estimate and cumulative lesion length ≥ 15 cm;
- •Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee);
- •Life expectancy >1 year in the Investigator's opinion;
- •Written informed consent.
- •Exclusion criteria:
- •Given the observational nature of the study, no study-specific but only clinical exclusion criteria will apply:
- •Patient unwilling or unlikely to comply with FU schedule;
- •Administration of local or systemic thrombolytic therapy within 48 hours prior to the index procedure;
- •Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel;
- •Additional planned cardiac or peripheral percutaneous or surgical intervention including CABG within 30 days following the study procedure;
- •15 cm long inflow lesion (≥50% DS) or occlusion (any length) in the ipsilateral Iliac artery;
- •Failure to successfully treat < 15 cm long inflow lesion in the ipsilateral Iliac artery
排除标准
- 未提供
结局指标
主要结局
rate of primary patency
时间窗: within the first 12 months after percutaneous treatment
Primary patency is defined as freedom from the combined endpoints of clinically-driven target lesion revascularization (TLR) and \>50% restenosis in the treated lesion. Clinically driven TLR is defined as any re-intervention within the target lesion due to symptoms or drop of ABI of ≥20% or \>0.15 when compared to post-procedure. Restenosis \> 50% is defined by a peak systolic velocity ratio (PSVR) \> 2.4.
次要结局
- composite of all Major Adverse Events (MAE)(within the first 24 months after percutaneous treatment)
- incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE)(within the first 24 months after percutaneous treatment)
- clinical improvement as assessed by Rutherford Class changes(within 6, 12 and 24 months vs baseline)