2025-521795-58-00招募中4 期
Contrast Strategy In Fenestrated EndoVascular Aneurysm Repair Randomized Control Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 243
- 试验地点
- 6
- 主要终点
- Incidence of patients with AKI, defined as RIFLE stage R (Risk) and above during the early postoperative period according to the RIFLE classification (Risk, Injury, Failure, Loss of kidney function, End-stage kidney disease) suggested in the reporting standards for complex aortic repair.
研究概览
简要总结
To explore if a strategy aimed at reducing the exposure to iodine contrast medium, achieved by preferentially using carbon dioxide (CO2) to visualize arteries during FEVAR when possible, reduces the postoperative incidence of AKI following FEVAR of abdominal aortic aneurysms compared to the standard of care.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •The subject has given their written consent to participate in the trial.
- •Planned elective FEVAR of juxtarenal or pararenal aneurysm aortic aneurysm within six months, using a customized fenestrated endograft based on stainless steel stents and polyester graft.
- •≥ 18 years old
- •For female participants in fertile age a negative pregnancy test is required followed by highly effective birth control methods after inclusion and until the termination of the trial.
排除标准
- •Severe COPD (Chronic Obstructive Pulmonary Disease)
- •Current participation in other clinical interventional trials (registers and non-interventional studies are allowed)
- •Pregnancy or breast feeding
- •Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial
- •Known atrium‐ or ventricular septal defect with right‐left‐shunt
- •Thyrotoxicosis
- •Severe renal arteries atherosclerosis (≥ 50%) in any of the renal arteries
- •Shaggy aorta
- •Distal extension of the disease requiring iliac branch devices or hypogastric embolization/coverage
- •Contrast agent allergy even if premedication is used
- •FEVAR done with anaesthesia other than general anaesthesia
- •Inflammatory or infective aneurysm
结局指标
主要结局
Incidence of patients with AKI, defined as RIFLE stage R (Risk) and above during the early postoperative period according to the RIFLE classification (Risk, Injury, Failure, Loss of kidney function, End-stage kidney disease) suggested in the reporting standards for complex aortic repair.
Incidence of patients with AKI, defined as RIFLE stage R (Risk) and above during the early postoperative period according to the RIFLE classification (Risk, Injury, Failure, Loss of kidney function, End-stage kidney disease) suggested in the reporting standards for complex aortic repair.
次要结局
- Kidney function; Incidence of patients developing AKI stage 1 and above, according to KDIGO classification, based on Serum creatinine assessment and urinary output
- Success of surgery; Number and percent of patients fulfilling the definitions of the immediate technical and primary and secondary clinical successes (calculated with the life-tables), based on clinical and imaging endpoints at the FEVAR and CT during follow-up at 1 months and yearly up to 3 years
- Intraoperative imaging assessment: - Image quality assessed by a 5-point Likert scale; -Incidence of detected endoleaks and their type; - Radiation exposure and Absorbed Dose
- Percentage of patients experiencing adverse events until discharge and adverse events of special interest up to 3 years after FEVAR (number, type and severity)
- The quality of life before and after the procedure measured by the EQ-5D-5l instrument preoperatively, at discharge, 1 month, and 1, 2, and 3 years
- Swedish Quality of Recovery Scale (SwQoR) at day 2 postoperatively; and MoCa before the procedure and at 1 month
- Survival up to 3 years (percent of surviving patients)
- Percentage of patients whose cause of death is related to aortic repair and renal insufficiency, up to 3 years after FEVAR
- Percentage of patients with CKD stage 2 and above within 3 years, according to the National Kidney Foundation Kidney Disease Outcomes Quality Initiative classification, based on the assessment of eGFR
- Percentage of patients with worsening of CKD stage within 3 years according to the National Kidney Foundation Kidney Disease Outcomes Quality Initiative classification, based on the assessment of eGFR
- Reintervention
研究者
Vascular Center, Skåne University Hospital Malmö
Scientific
Region Skane
研究点 (6)
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