NCT02307292Unknown不适用
Prospective, Non-randomized Post Market Surveillance Registry to Document the Clinical Performance in Routine Clinical Practice of the POLARIS Peripheral Vascular Self Expanding Stent System.
QualiMed Innovative Medizinprodukte GmbH1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2014年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Freedom from target lesion revascularization
研究概览
简要总结
This is a prospective, non-randomized post market surveillance registry designed to document the clinical Performance in Routine clinical practice of the POLARIS Peripheral Vascular Self Expanding Stent System
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Single target de novo superficial femoral artery lesion (angiographic evidence of >50% Stenosis or occlusion) by visual estimate
- •Rutherford category II-IV
- •At least one patent outflow artery to the ankle.
- •Patient signed the informed consent
排除标准
- •Patient with acute or subacute Thrombus
- •Patients with hyperkoagulopathy
- •Patients with Stenosis or occlusion where lesion crossing with guide wire is not possible
- •Pregnancy or positive pregnancy test
- •Previous enrolment in this Trial or other industrial Trials
- •Patient´s inability to fully cooperate with the registry protocol Patient with cancer Treatment (life expectancy less than 2 years) Patients with renal failure
结局指标
主要结局
Freedom from target lesion revascularization
时间窗: at 12 months
Clinically driven
次要结局
- Change in Rutherford Classification(From baseline to 12 and 24 months)
- Binary restenosis/ reocclusion(at 12 months)
- Target limb amputation at the index leg (major and minor separately)(at 12 months)
- All-cause death(at 12 months)
- Change in resting ankle brachial index (ABI)(From baseline to 12 and 24 months)
研究者
Hans Krankenberg
MD PhD
Herz- und Gefaesszentrum Bad Bevensen
研究点 (1)
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