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临床试验/NCT03262467
NCT03262467已完成不适用

Aneurysmorrhaphy of Vascular Access for Haemodialysis

Faculty Hospital Kralovske Vinohrady1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2018年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
115
试验地点
1
主要终点
Patency and aneurysms recurrence at 12 months after operation

研究概览

简要总结

In patients with chronic renal failure, a well-functioning vascular access is essential for hemodialysis treatment. Native arteriovenous fistula (AVF) is the first-choice of vascular access, due to a lower incidence of complications and better long-term patency as compared to prosthetic arteriovenous fistula. With the incidence ranging between 6-60%, AVF aneurysm (AAVF) is a common complication of native AVF. According to Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines, asymptomatic aneurysms are indicated for conservative treatment, but precise recommendations when and how to intervene in available guidelines are missing.

Several surgical (remodeling, resection and substitution, ligation) and endovascular techniques have been described in the AAVF treatment, but there is currently no prospective randomized study comparing these techniques.

In 2008, our team published the first experience with a new surgical method of AAVF treatment - aneurysmorrhaphy with external porous prosthesis (Provena©, BBraun). This therapy was validated in several studies and has shown a good long-term patency and a minimal incidence of complications.

AAVF aneurysmorrhaphy can be performed with or without an external porous prosthesis (Provena©, BBraun). The use of external prostheses reduces venous wall shear stress, turbulent flow, endothelial damage, and thrombus formation, which should improve vascular patency and reduce the risk of AVF re-aneurysm. So far, there is no prospective randomized study comparing the effect of external porous prosthesis on AVF patency and the incidence of postoperative complications.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signature of informed consent.
  • A male or female subject aged 18 or older.
  • A subject with a naive vascular access aneurysm indicated for surgical treatment.

排除标准

  • Patients with pseudoaneurysm of prosthetic vascular access
  • Patients with a vascular access infection

结局指标

主要结局

Patency and aneurysms recurrence at 12 months after operation

时间窗: 12 months

次要结局

  • Complications at 12 months(12 months)

研究者

发起方
Faculty Hospital Kralovske Vinohrady
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Peter Balaz

Principal Investigator

Faculty Hospital Kralovske Vinohrady

研究点 (1)

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