ACTRN12614000094673已完成未知
Clinical Evaluation of the Advance (Registered Trademark) 35 Scoring Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter in treating stenoses of a mature native arteriovenous (AV) hemodialysis access circuit
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •1. A greater than 50% stenosis (when compared to the reference vessel diameter) of a mature native AV dialysis access circuit in the upper extremity
- •2. Clinical or physiological abnormalities which indicate dialysis access dysfunction
排除标准
- •1. Any related surgical or interventional procedure of the access circuit less than or equal to 30 days prior to the enrollment
- •2. Medical condition or comorbid conditions that would limit life expectancy to less than 6 months
- •3. Scheduled for a kidney transplant
- •4. Known hypersensitivity or contraindication to contrast agent that, in the opinion of the investigator, cannot be adequately pre-medicated
- •5. Synthetic AV dialysis access graft
- •6. Current or previous history of thrombosis anywhere within the AV dialysis access circuit
- •7. Evidence of systemic or local infection associated with the AV dialysis access circuit
- •8. History of bleeding diathesis or coagulopathy or will refuse blood transfusions
- •9. Stent or stent graft in the AV dialysis access circuit
- •10. Hemodynamically significant central venous stenosis, unless successfully treated prior to treating the study lesion
- •11. Presence of occlusion in the AV dialysis access circuit such that a guidewire cannot pass through the lesion
- •12. Target lesion is greater than or equal to 4 cm in length
- •13. Reference vessel diameter is greater than 12 mm
- •14. Presence of more than two distinct lesions (stenoses) in the AV dialysis access circuit
研究者
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