ChiCTR-INR-17010350
尚未开始
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2017-01-06
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动静脉内瘘狭窄
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
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
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.
随机平行对照
治疗新技术
60 patients randomized into 2 groups, 30 in experimental group, 30 in control group
Open label
NA
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30
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1990-01-01
1990-01-01
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Percutaneous Transluminal Angioplasty will performed in end-stage renal failure patients with hemodynamically significant (defined as >50%) stenosis of the autogenous fistula.；
登录查看- 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；
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