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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
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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Record updated
25 June 2026