Not yet taking people in DenmarkPhase 4
Contrast Strategy In Fenestrated EndoVascular Aneurysm Repair Randomized Control Trial
Key facts
- Who runs it
- Region Skane
- Where
- Aarhus N and Copenhagen Oe, DenmarkSee the 2 sitesAlso in 1 other country, 6 sites
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 4
- People taking part
- 293 people, planned
- Started
- 1 Jan 2026
- Expected to end
- 31 Dec 2031
- Type of study
- Interventional
- Record updated
- 25 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Denmark
Also in 1 other country, 6 sites
- Aarhus UniversitetAarhus N, DenmarkNot yet recruiting
- RigshospitaletCopenhagen Oe, DenmarkNot yet recruiting
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Record updated
- 25 June 2026