A Prospective Observational Study Using Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 10
- 主要终点
- Change of Rutherford Classification
研究概览
简要总结
The aim of this observational study is to evaluate the outcomes and safety of the Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease (PAD) in below-the-knee vessels
详细描述
The management of critical limb ischemia due to below-the-knee disease remains challenging due to the frequent patient comorbidities, diffuse vascular involvement, limb preservation, and high rates of restenosis and disease progression. This study will record the use of ELUTAX SV-DEB under real life conditions in a representative sample.The investigators will generate new data in observing the outcome and the safety of the Elutax SV drug-eluting balloons for change in Rutherford clinical category from baseline to 6 and 12 month follow-up visits.
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
- •Paclitaxel-eluting balloon angioplasty in below-the-knee lesions with ELUTAX SV-DEB
- •Age ≥ 18 years
- •Signed informed consent
- •documented Critical Limb Ischemia (CLI) in the target limb prior to the study
- •Rutherford Category 4, 5 or 6
- •≥70% diameter stenosis or occlusion in the target lesion, including de-novo / in-stent restenosis/occlusion of target lesion
- •Patent inflow artery
- •Target vessel(s) diameter between 2 and 4 mm
- •Target vessel(s) reconstitute(s) at or above the ankle
排除标准
- •Life expectancy below 50% within the next 12 months (as judged by the investigator)
- •Planned major index limb amputation
- •Acute limb ischemia (within last 14 days thrombectomy, atherectomy, or lysis)
- •Application of DEB-eluting balloons except from ELUTAX SV in the same target limb (POBA is allowed)
- •Patient unwilling or unlikely to comply with follow-up schedule
结局指标
主要结局
Change of Rutherford Classification
时间窗: after 6 and 12 month
Change of Rutherford stage to baseline at Follow-up visits
次要结局
未报告次要终点
研究者
Ulf Teichgräber
Prof. Dr. med.
Jena University Hospital