NCT03528811Unknown1 期
Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes
Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Coincidence rate of "5 points test of Tongji university"
研究概览
简要总结
The main aim of the present study was to evaluate the microcirculation of peripheral vascular disease in diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Patients with Peripheral vascular disease with or without diabetes. 2.Rutherford class 2-
- •3.Target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention.
- •4.Target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length.
- •5.Written informed consent signed by the patients or representatives
排除标准
- •1.Previous bypass surgery or stent placement at the ipsilateral lower limb 2.History of intolerance to antiplatelet therapy, heparin, or contrast media. 3.Bleeding diathesis; 4.Active systemic bacterial infection; 5.Severely impaired renal function (serum creatinine level > 2.5 mg/dL. Expected survival time of less than 24 months
研究组 & 干预措施
Five points test of Tongji university
Other
We established the evaluatation and follow-up system of diabetes vascular disease based on the method called "Five points test of Tongji university" .
干预措施: Five points test of Tongji university (Diagnostic Test)
结局指标
主要结局
Coincidence rate of "5 points test of Tongji university"
时间窗: 12 months
The primary study endpoint was that the coincidence rate of evaluating the microcirculation by the newly-established "5 points test of Tongji university" attains over 95% before and after operations as assessed by digital substraction angiography (DSA).
次要结局
未报告次要终点
研究者
Maoquan Li
Chief Physician
Shanghai 10th People's Hospital
研究点 (1)
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