Renal Function After Stentgraft Treatment Of Abdominal Aneurysm With Supra- Versus Infrarenal Fixation - a Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Number of participants with decreased renal function (composite endpoint together with the endpoint below)
研究概览
简要总结
This randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm (AAA) with stentgrafts either with active supra- or infrarenal fixation.
详细描述
This randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm with stentgrafts either with active supra- or infrarenal fixation. Individuals are planned to be included throughout Scandinavia. After inclusion in the study, baseline data is collected and computerized randomization between the two stent graft fixation types is performed. Follow-up will be scheduled after 1 month and 1,3 and 5 years. Analyses of blood samples to determine renal function are undertaken together with CT scans to detect stentgraft performance at all follow-up visits alongside assessments of health-related quality of life questionnaires.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The type of stentgraft is masked for participants, investigators and outcome assessors as the journal chart and information about implanted device are made not accessible for the above mentioned individuals, and all data will be gathered in an Electronic Case Report Form (eCRF) with stentgraft information masked.
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
- 是
入选标准
- •Willing and able to provide written informed consent
- •Meet criteria for non-ruptured infrarenal/iliac aneurysm
- •Suitable anatomy for treatment with an approved device (CE-marked) stentgraft according to the manufacturers' instructions for use for AAA.
- •Accepted for treatment with endovascular aortic repair (EVAR) by the participating vascular center.
排除标准
- •Ongoing or planned dialysis
- •AAA treatment requiring stents or stentgrafts in renal and/or visceral arteries
- •Inability to independently complete HRQoL questionnaires due to language barriers
- •Anatomical preconditions that do not allow both types of fixation to be used interchangeably, i.e. very advanced suprarenal tortuosity (>60 degrees), advanced suprarenal dilatation or infrarenal thrombus >25% of circumference.
结局指标
主要结局
Number of participants with decreased renal function (composite endpoint together with the endpoint below)
时间窗: Change between baseline renal function and at 3 years.
Decrease of more than 20 percent in estimated Glomerular Filtration Rate (eGFR) after stentgraft treatment.
Number of participants with new renal infarct
时间窗: Change in numbers of new renal infarcts between baseline and at 3 years.
Diagnosed new renal infarct on CT scan after treatment
次要结局
- Number of participants with aneurysm related mortality(From treatment and 1, 3 and 5 years postoperatively)
- Number of participants with continuing aneurysm growth(From treatment and 1, 3 and 5 years postoperatively)
- Number of participants with decreased renal function and new renal infarct (Analysis of the individual components of the primary composite endpoint at 1, 3 and 5 years).(From treatment and 1, 3 and 5 years postoperatively)
- Number of participants with stentgraft thrombosis(From treatment and 1, 3 and 5 years postoperatively)
- Number of participants with decreased score in quality of life-questionnaire(From treatment and 1 and 3 years postoperatively)
- Number of participants with aneurysm related hospitalizations(From treatment and 1, 3 and 5 years postoperatively)
- Number of participants with new diagnosis of cancer(From treatment and 1, 3 and 5 years postoperatively)