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Contrast Strategy In Fenestrated EndoVascular Aneurysm Repair Randomized Control Trial

Status
Not yet recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521795-58-00
Enrollment
243
Registered
2025-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal aortic aneurysm

Brief summary

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.

Detailed description

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

Interventions

DRUGOmnipaque 180 mg I/ml Injektionslösung
DRUGIomeron 150 mg I/ml injektionsvätska
DRUGlösning
DRUGVisipaque 270 mg I/ml Injektionslösung

Sponsors

Region Skane
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026