International Postmarketing Surveillance Study of Pl-VEGF165 Safety and Efficacy in 210 Patients With Peripheral Arterial Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 30
- 主要终点
- Change in the measurement of pain-free walking distance (PWD) on treadmill
研究概览
简要总结
Aim of the study is to gain more knowledge about efficacy and safety of Neovasculgen® in daily clinical practice and obtain information about the quality of life in patients treated with Neovasculgen®.
详细描述
This is an open, controlled, prospective, comparative, multicentre study design. All patients received standard conservative therapy for chronic limb ischemia without cilostazol and prostaglandins and without surgical or endovascular vessel reconstruction. Surgical and endovascular vessel reconstruction was unsuitable for all of the patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female person aged 40 or older
- •Subject with diagnosed lower limb ischemia (Fontaine-Pokrovsky Stages IIa-III of chronic limb ischemia)
- •Signed informed consent
排除标准
- •Any disease that can, in the opinion of the treating physician, affect the outcome of the study
- •Patients with addictive disorders or substance abuse
- •Pregnancy or nursing
- •All other exclusion criteria listed in the summary of product characteristics (SmPC)
研究组 & 干预措施
Neovasculgen®
Single group prospective treatment
干预措施: Neovasculgen® (Drug)
standard care
干预措施: Neovasculgen® (Drug)
结局指标
主要结局
Change in the measurement of pain-free walking distance (PWD) on treadmill
时间窗: 3 months and 6 months after the first injection of Neovasculgen®.
次要结局
- Number of adverse drug reactions (ADRs) and unexpected adverse drug reactions (UADRs)(From the first injection of Neovasculgen® until six months after the secondary injection of Neovasculgen®)
- Change in the ankle-brachial index (ABI) after injection of Neovasculgen®(3 months and 6 months after the first injection of Neovasculgen®)
- Change in blood flow linear velocity (BFLV) after injection of Neovasculgen®(3 months and 6 months after the first injection of Neovasculgen®)
- Change in transcutaneous oxygen tension measurements (TcPO2) after injection of Neovasculgen®(3 months and 6 months after the first injection of Neovasculgen®)