Contrast Strategy In Fenestrated EndoVascular Aneurysm Repair Randomized Control Trial
A legfontosabb adatok
- Fázis
- 4. fázis
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Contact the study team: see the registry record
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Region Skane
- Azonosító
- EU 2025-521795-58-00
- A regiszteradat frissítve
- 2026. június 25.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: Severe COPD (Chronic Obstructive Pulmonary Disease); Distal extension of the disease requiring iliac branch devices or hypogastric embolization/coverage; Contrast agent allergy even if premedication is used; 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; FEVAR done with anaesthesia other than general anaesthesia; Inflammatory or infective aneurysm.