About this trial
This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention.
The enrollment period will be of 65 months (01/jan/2020-30/jun/2025). Sample size will be of 100 patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>18 years old
Renal artery: >2 cm if fusiform morphology or all dimensions if sacculary or bifurcation morphology, if in fertile women or in hypertensive patients with renal stenosis
Splenic artery: if >2 cm, or all dimensions in fertile women.
Celiac tripod: if >2 cm.
Disqualifiers
patients who are hemodynamically unstable or show CT signs of rupture or contained rupture of visceral aneurysm
pregnant or breastfeeding women
life expectancy less than 2 years
Trial population
Men and women \>18 years old with the presence of a visceral aneurysm.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Visceral aneurysm stenting
DeviceFlow diverter stenting
Treatment groups
Trial outcomes
Primary outcomes
Efficacy of the stenting in terms of patency and side branches
stent patency and side branches (the absence of stenosis greater than 50% of the stent's internal lumen and the side branches' lumen)
Efficacy of the stenting in terms of aneurysm thrombosis rate
aneurysm (partial or complete, \>50% or 100%) thrombosis
Efficacy of the stenting in terms of aneurysm volume assessment
aneurysm volume assessment (percentage of volume reduction respect to the initial volume)
Safety in terms of morbidity
morbidity (any adverse events occured during follow up for any causes and by causes associated with treatment)
Sponsors and contacts
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