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【ChiCTR-INR-17010350】比較折疊球囊導管血管成形術與傳統球囊導管血管成形術的隨機臨床試驗

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基本信息

登记号

ChiCTR-INR-17010350

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2017-01-06

临床申请受理号

靶点

适应症

动静脉内瘘狭窄

试验通俗题目

比較折疊球囊導管血管成形術與傳統球囊導管血管成形術的隨機臨床試驗

试验专业题目

比較折疊球囊導管血管成形術與傳統球囊導管血管成形術的隨機臨床試驗

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

The primary objective is to evaluate at post-operation, 1 month, 6 months and 12 months follow-ups the safety and efficacy of scoring balloon for AV Fistula based on primary patency of target lesions in experimental and control groups.

试验分类

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试验类型

随机平行对照

试验分期

治疗新技术

随机化

60 patients randomized into 2 groups, 30 in experimental group, 30 in control group

盲法

Open label

试验项目经费来源

试验范围

目标入组人数

实际入组人数

第一例入组时间

1990-01-01

试验终止时间

1990-01-01

是否属于一致性

入选标准

Percutaneous Transluminal Angioplasty will performed in end-stage renal failure patients with hemodynamically significant (defined as >50%) stenosis of the autogenous fistula.；

排除标准

- Patient refusing treatment - The reference segment diameter is not suitable for available catheter design - Previous PTA for the same lesion - Associated significant (>50%) central venous stenosis - Multiple significant (>50%) stenosis - The patient is minor (<18 years old) - Previous access thrombectomy - Positive pregnancy test result within 7 days before enrolment - Patient is scheduled for a kidney transplant - Life expectancy <6 months - The patient has a known allergy to heparin, aspirin or other anticoagulant/ antiplatelet therapies - The patient is currently enrolled in another investigational device or drug trial - The patient is currently breast-feeding, pregnant or intends to become pregnant；

研究者信息

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试验机构

Princess Margaret Hospital

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研究负责人邮编

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