Characterization of STEnotic Lesion Type of Haemodialysis Arteriovenous Fistulae by Ultrasonography and Correlation With the Outcomes of Percutaneous Transluminal Angioplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Lesion characterization
研究概览
简要总结
The continuous increase in the incidence of end stage renal disease and hemodialysis patients, has raised the interest of the vascular access scientific community and many researchers are currently investigating the potential mechanisms of arteriovenous fistulas (AVF) dysfunction. Roy-Chaudhury et al. were the first to suggest neointimal hyperplasia (NIH) as the main reason of AVF dysfunction and vessel negative remodeling as another important factor. First, Yamamoto et al. described 3 stenotic lesions categories of arteriovenous grafts (AVG) observed by ultrasonography: 1. vascular constriction type, 2. neointimal hyperplasia type, 3. mixed type (constriction and neointimal hyperplastic type).
The main goals of this prospective observetional study are:
- The characterization of AVF stenotic lesions by ultrasonography
- The correlation of the stenotic lesion type with the outcomes of percutaneous transluminal angioplasty and the rate of reintervention.
详细描述
This is a prospective, observetional study designed to investigate the correlation of stenotic lesion type characterization (1. vascular constriction type, 2. neointimal hyperplasia type, 3. mixed type eg. constriction and neointimal hyperplastic type) using Duplex ultrasound, with the outcomes of high pressure plain balloon angioplasty. In total 200 patients with failing dialysis arteriovenoyus fistula (AVF) scheduled to undergo angioplasty of stenotic lesion(s) will be included. The study's primary endpoint will be the correlation between stenotic lesion type and target lesion re-intervention due to clinical recurrence at 6 months follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patiens with failing AVF scheduled to undergo fluoroscopically-guided high-pressure balloon angioplasty
- •Signed study concent form
排除标准
- •Patients undergoing dialysis via arteriovenous graft (AVG)
- •Contraindications to angioplasty
- •Immature AVF
结局指标
主要结局
Lesion characterization
时间窗: Less than 48 hours before the procedure
Lesion type will be classified as restrictive, hyperplastic or mixed based on the pre-procedural Duplex ultrasound assessment and the rates of each type will be recorded.
Correlation of target lesion reintervention (TLR) due to clinical recurrence and lesion type
时间窗: 6 months
The correlation of the speciific lesion type classified based on the pre-procedural ultrasonographic assessment and the target lesion reintervention rate due to clinical recurrence, will be investigated
次要结局
- AVF survival(6 months)
- Restenosis characterization post angioplasty(6 months)
- Periprocedural complication rate(Up to 48 hours post-procedure)
- Binary restenosis rate(6 months)
研究者
Stavros Spiliopoulos
Associate Professor of Diagnostic and Interventional Radiology
Attikon Hospital