Aortic Aneurysm, Aortic Aneurysm, Thoracic, Aortic Arch Aneurysm, Aortic Diseases, Stroke
Conditions
Keywords
endovascular, evar, tevar, stentgraft, de-airing
Brief summary
Non-randomized studies have shown that de-airing of the delivery system with an increased volume of saline may be associated to a decrease in periprocedural stroke during thoracic endovascular aortic repair. This study is designed to provide evidence that 4xIFU-dose volume of saline flush vs. standard IFU-dose saline flush is associated to a decrease in the amount of intra-sac air detected on the first follow-up imaging after EVAR.
Interventions
PROCEDUREIncreased saline flush volume
Additional flushing of the stentgraft delivery system.
Sponsors
Semmelweis University Heart and Vascular Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* endovascular aortic repair of an abdominal aortic aneurysm using either of these devices: Terumo/Bolton Treo, Terumo Anaconda, Cook Zenith Alpha Abdominal
Exclusion criteria
* concomitant use of an iliac bifurcation device due to insufficient common iliac landing zone on either side
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Air volume | within 7 days after index procedure | Total volume of air inside the aneurysm sac on discharge CT imaging. |
Countries
Hungary
Outcome results
None listed