NCT01321866终止不适用
Randomized Trial Comparing a Cutting Balloon to a Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2012年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Primary patency
研究概览
简要总结
The main objective of this study is to evaluate and compare the primary patency rate at 12 months in a group of hemodialysis patients operated on by cutting balloon and in a group of hemodialysis patients operated by conventional balloon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 12 months of follow-up
- •The patient is on hemodialysis because of chronic renal insufficiency
- •The patient's vascular access is an arterio-venous fistula
- •The patient has a venous stenosis in the fistula (first event in the studied zone)
- •The patient is scheduled for angioplasty
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient cannot fluently read French
- •The patient cannot understand French
- •The patient is pregnant
- •The patient is breastfeeding
- •Short term dialysis
- •The vascular access is a "graft"
- •The stenosis in question is a recurrence, and not a first event in the studied zone
- •The life expectancy of the patient is < 12 months
- •Medical emergency situation
- •Peritoneal dialysis
- •At-home dialysis
研究组 & 干预措施
Experimental arm
Experimental
Patients in this arm will have angioplasty of a fistula stenosis using a cutting balloon
干预措施: Cutting balloon angioplasty (Procedure)
Standard arm
Active Comparator
Patients in this arm will have angioplasty of a fistula stenosis using a non-cutting balloon.
干预措施: Angioplasty (Procedure)
结局指标
主要结局
Primary patency
时间窗: 12 months
Primary patency following a first angioplasty of a first stenose in the affected zone.
次要结局
- Presence/absence of complications associated with the angioplasty(Day of intervention)
- Questionnaire KDQOL(6 months)
- Direct medical costs (€)(12 months)
- Questionnaire SF36(6 months)
- % Stenosis(3 months)
- Number of early re-stenoses(3 months)
- Number of re-stenoses(12 months)
- Number of stents used(12 months)
- Total number of venous thromboses(12 months)
- Fistula quality (cm*ml/min)(12 months)
- Total days in hospital(12 months)
- Indirect costs (€)(12 months)
- Presence/absence of complications since the last visit(12 months)
- Questionnaire KDQOL(12 months)
- Questionnaire SF36(12 months)
- Questionnaire KDQOL(3 months)
- Questionnaire SF36(3 months)
- Fistula quality (cm*ml/min)(Baseline)
- Fistula quality (cm*ml/min)(6 months)
- % Stenosis(Baseline)
- % Stenosis(6 months)
- % Stenosis(12 months)
- Presence/absence of complications since the last visit(6 months)
研究者
研究点 (1)
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