NCT01458041已完成不适用
Iloprost Therapy in Patients With Critical Limb Ischemia: Evaluation of Efficacy and Safety
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 126
- 主要终点
- Change of limb pain at rest assessed by visual analogue scale
研究概览
简要总结
Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.
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
- •Patients who fulfill the internationally defined criteria of critical limb ischemia;
- •Patients who are not eligible for vascular surgery or angioplasty interventions and
- •Patients who are treated with iloprost infusion.
- •The treating physician has decided iloprost treatment before study enrollment.
排除标准
- •Exclusion criteria are in accordance with the Summary of Product Characteristics of Ilomedin.
研究组 & 干预措施
Group 1
干预措施: Iloprost (Ilomedin, BAYQ6256) (Drug)
结局指标
主要结局
Change of limb pain at rest assessed by visual analogue scale
时间窗: At baseline, at the end of iloprost treatment, at follow-up visits ( month 3, 6, 12)
Pain relief will be defined as complete relief of pain while off analgesics
次要结局
- Collection of interventional / surgical procedures including 1) Rate of revascularization procedures; 2) Minor amputations; 3) Frequency and height of major amputations(at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12))
- Mortality and/or severe cardiovascular events (AMI, stroke)(at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12))
- Incidence of ulcer healing(at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12))
- Hemodynamic measurements: peripheral arterial blood flow and pressure on ankle / hallux level by Doppler scanner(at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12))
- Changes of transcutaneously measured tissue oxygen tension values(at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12))
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