KCT0009282招募中Unknown
Comparison of SUPERA vs Plain old balloon angioplasty(POBA) on recurrent cephalic arch stenosis in patients with brachiocephalic arteriovenous fistula
Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19(Year) 至 90(Year)（—）
- 性别
- All
入选标准
- •1. Selection criteria for subjects undergoing only balloon angioplasty (POBA)
- •1) Those who consented to the study (Informed consent obtained)
- •2) Patients aged =21 years and =90 years (Patient aged =21 years and =90 years)
- •3) Among end-stage renal failure (ESRD) patients on hemodialysis, subjects with brachial artery-northermal cutaneous vein arteriovenous arch stenosis in the brachial artery-lateral cutaneous vein arteriovenous fistula
- •4) Subjects who can continuously take aspirin or clopidogrel 5]6]
- •5) Patients with significant recurrent CAS within 6 months of initial POBA, diagnosed either Clinically or with Duplex ultrasound)
- •6) When residual stenosis is <10% after balloon anastomosis (POBA)
- •2. Selection criteria for subjects undergoing SUPERA stent insertion surgery
- •1) Those who consented to the study (Informed consent obtained)
- •2) Patients aged =21 years and =90 years (Patient aged =21 years and =90 years)
- •3) Among end-stage renal failure (ESRD) patients on hemodialysis, subjects with brachial artery-northermal cutaneous vein arteriovenous arch stenosis in the brachial artery-lateral cutaneous vein arteriovenous fistula
- •4) Subjects who can continuously take aspirin or clopidogrel 5]6]
- •5) Patients with significant recurrent CAS within 6 months of initial POBA, diagnosed either Clinically or with Duplex ultrasound)
- •6) Among patients with recurrence of lateral cutaneous venous arch stenosis, those with a maximum diameter of lateral cutaneous venous arch between 5 and 7 mm after angiography (Post angioplasty cephalic arch lumen size between 5 and 7 mm maximum diameter)
- •7) If the blood flow disorder is not resolved due to blood vessel dissection or physical compression, or if residual stenosis is > 10% even after multiple balloon angioplasty (POBA) using rigid/cutting balloons
- •*Rigid/cutting balloon (CB) is a catheter for cardiovascular plastic surgery in which three or four metal blades are vertically attached to the surface of the balloon. It cuts the blood vessel wall by making a deliberate incision in the blood vessel wall before full-scale blood vessel dilatation. A device designed to minimize damage.
排除标准
- •1) When lateral cutaneous venous arch stenosis is <50% or diameter >7 mm (CAS <50% stenosis or diameter >7 mm)
- •2) Patients who previously underwent BMS (bare metal stent) on the lateral cutaneous venous arch (Patients with previous cephalic arch stenting bare metal stents or stent graft [SG])
- •3) If there is a concomitant fistula inflow problem [e.g. juxta-anastomotic] that cannot be corrected optimally during the procedure [residual stenosis of 30% or more or vessel lumen diameter of 3 mm or less] during the intervention[>30% residual stenosis or angiographic lumen of <3 mm])
- •4) Cases where minor or major rupture occurs in the lateral cutaneous venous arch during balloon angioplasty (POBA) procedure and the rupture point cannot be properly sealed with open surgery or stents (Patients with minor or major cephalic arch rupture during POBA procedure and the rupture point cannot be adequately sealed off during the procedure requiring a covered stent or open conversion)
- •5) Cephalic arch lesion length of <10 mm or greater than 10 cm
- •6) Patients with uncontrolled hypertension
- •7) Pregnant women or women of childbearing potential who are not following an effective method of contraception
- •8) Subjects who cannot use aspirin or clopidogrel (Contraindication to aspirin or clopidogrel usage)
- •9) Subjects who are not cooperative in participating in the study (Uncooperative attitude or potential for non-compliance with the requirements of the protocol making study participation impractical)
- •10) Patients who do NOT have hemodialysis
- •11) Subjects with occluded or thrombosed fistula
- •12) Subjects with concomitant central venous stenosis
- •13) Where final angioplasty treatment requires a stent >8 mm in diameter
- •14) Subjects with blood coagulation disorders
- •15) When life expectancy is less than 6 months (Limited life expectancy [<6 months])
- •16) Sepsis or active infection
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