Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Turin, Italy

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 volunteers

Qualifiers

>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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Visceral aneurysm stenting

    Device

    Flow diverter stenting

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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)

Time frame
12 months
2

Efficacy of the stenting in terms of aneurysm thrombosis rate

aneurysm (partial or complete, \>50% or 100%) thrombosis

Time frame
12 months
3

Efficacy of the stenting in terms of aneurysm volume assessment

aneurysm volume assessment (percentage of volume reduction respect to the initial volume)

Time frame
12 months
4

Safety in terms of morbidity

morbidity (any adverse events occured during follow up for any causes and by causes associated with treatment)

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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