IOHEXOL for Abdominal aortic aneurysm

Inclusion criteria

• {"criterion_text":"- The subject has given their written consent to participate in the trial."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- ≥ 18 years old"}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- Severe COPD (Chronic Obstructive Pulmonary Disease)"}
• {"criterion_text":"- Current participation in other clinical interventional trials (registers and non-interventional studies are allowed)"}
• {"criterion_text":"- Pregnancy or breast feeding"}
• {"criterion_text":"- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial"}
• {"criterion_text":"- Known atrium‐ or ventricular septal defect with right‐left‐shunt"}
• {"criterion_text":"- Thyrotoxicosis"}
• {"criterion_text":"- Severe renal arteries atherosclerosis (≥ 50%) in any of the renal arteries"}
• {"criterion_text":"- Shaggy aorta"}
• {"criterion_text":"- Distal extension of the disease requiring iliac branch devices or hypogastric embolization/coverage"}
• {"criterion_text":"- Contrast agent allergy even if premedication is used"}
• {"criterion_text":"- FEVAR done with anaesthesia other than general anaesthesia"}
• {"criterion_text":"- Inflammatory or infective aneurysm"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"AKI defined by RIFLE classification (R and above) during early postoperative period as per RIFLE reporting standards for complex aortic repair."}

Secondary endpoints

• {"endpoint_text":"- Kidney function; Incidence of patients developing AKI stage 1 and above, according to KDIGO classification, based on Serum creatinine assessment and urinary output","definition_or_measurement_approach":"KDIGO classification based on serum creatinine assessment and urinary output."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Technical and clinical success assessed by clinical and imaging endpoints at FEVAR and CT at 1 month and annually up to 3 years; calculation with life-tables."}
• {"endpoint_text":"- Intraoperative imaging assessment: - Image quality assessed by a 5-point Likert scale; -Incidence of detected endoleaks and their type; - Radiation exposure and Absorbed Dose","definition_or_measurement_approach":"Image quality by 5-point Likert scale; recording incidence and type of endoleaks; radiation exposure and absorbed dose measured/reported intraoperatively."}
• {"endpoint_text":"- Percentage of patients experiencing adverse events until discharge and adverse events of special interest up to 3 years after FEVAR (number, type and severity)","definition_or_measurement_approach":"Adverse events collected until discharge and up to 3 years; number, type and severity recorded."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"EQ-5D-5L instrument administered preop, at discharge, 1 month, 1, 2 and 3 years."}
• {"endpoint_text":"- Swedish Quality of Recovery Scale (SwQoR) at day 2 postoperatively; and MoCa before the procedure and at 1 month","definition_or_measurement_approach":"SwQoR on day 2 post-op; MoCA administered pre-procedure and at 1 month."}
• {"endpoint_text":"- Survival up to 3 years (percent of surviving patients)","definition_or_measurement_approach":"Survival status assessed up to 3 years; percent surviving reported."}
• {"endpoint_text":"- Percentage of patients whose cause of death is related to aortic repair and renal insufficiency, up to 3 years after FEVAR","definition_or_measurement_approach":"Cause of death adjudicated and percentage related to aortic repair and renal insufficiency reported up to 3 years."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"CKD staging by NKF KDOQI classification using eGFR measured during follow-up up to 3 years."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Change in CKD stage by NKF KDOQI classification using serial eGFR over 3 years."}
• {"endpoint_text":"- Reintervention","definition_or_measurement_approach":"Number and occurrence of reinterventions recorded during follow-up."}

Sweden

Earliest CTIS Part Ii Submission Date

06-11-2025

Latest Decision Or Authorization Date

16-12-2025

Processing Time Days

40

Number Of Sites

6

Number Of Participants

243

Primary sponsor

Full Name

Region Skane

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"Sweden","full_name":"Region Skane Skanes Universitetssjukhus","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Educational Institution"}