REtrospective Analysis on the Use of COvered Stents for the Treatment of the Dysfunctional Vascular Access
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 主要终点
- Safety: Procedural Complications
研究概览
简要总结
This will be a multi-center, multi-national, investigator-initiated and lead, retrospective analysis assessing the safety and the clinical use of covered stents for the treatment of dysfunctional vascular access.
详细描述
This will be a multi-center, multi-national, investigator initiated and lead retrospective analysis assessing the safety and the clinical use of covered stents for the treatment of the dysfunctional vascular access.
There are no limitations on the type of covered stent use, the reason, or the length of the treatment area. The only limitations are the one owed to covered stent diameter and that patients included in the study should be treated for only one treatment area.
The criteria for inclusion, the outcome measures and the variables that should be recorded are listed below.
There is also no limitation if data has been previously published in another study, however data as part of an ongoing study, or of a study in press cannot be submitted.
Due to previous experience from similar studies it is known that it will be difficult to have data available for all re-interventions. Thus, study will focus on primary patency and safety. Nevertheless, centers should provide data regarding circuit survival (thrombosis, abandonment, surgical revision, patient's death). Terms and definitions of outcome measures are provided below.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years and <80 years
- •Patient on Dialysis with an Arteriovenous Fistula (AVF) or Graft (AVG)
- •Clinical Signs of Vascular Access Dysfunction or presence of a Pseudoaneurysm or Intraprocedural Vessel Rupture
- •Use of Covered Stent(s) for treatment
- •Minimum follow-up: 6 months
排除标准
- •>1 treatment areas included per procedure
- •Covered Stent not available in the market any more
结局指标
主要结局
Safety: Procedural Complications
时间窗: 30 days
Procedure-related Minor Complications No therapy, no consequence Nominal therapy, no consequence; includes overnight admission for observation only Procedure-related Major Complications Require therapy, minor hospitalization (\<48 hours). Require major therapy, unplanned increase in level of care, Prolonged hospitalization (\>48 hours). Permanent adverse sequelae Death
Effectiveness: Clinically assessed intervention-free period of the treated segment
时间窗: 6 months
A dialysis access circuit with no need for clinically driven treatment area repeat intervention for symptom recurrence and angiographic verification of the presence of stenosis at the treatment area.
次要结局
- Postintervention assisted primary patency(12 months)
- Access Circuit Primary Patency(12 months)
- Anatomic success(12 months)
- Clinically assessed intervention-free period of the treated segment(12 months)
研究者
Panagiotis Kitrou
Assistant Porfessor in Interventional Radiology
University Hospital of Patras