Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2
Condition(s) studied
Investigational drug(s) / intervention(s)
Visceral aneurysm stenting: Flow diverter stenting
Study summary
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
Primary outcome measure(s)
- Efficacy of the stenting in terms of patency and side branches — 12 months
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 — 12 months
aneurysm (partial or complete, \>50% or 100%) thrombosis - Efficacy of the stenting in terms of aneurysm volume assessment — 12 months
aneurysm volume assessment (percentage of volume reduction respect to the initial volume) - Safety in terms of morbidity — 12 months
morbidity (any adverse events occured during follow up for any causes and by causes associated with treatment) - Safety in terms of mortality — 12 months
mortality (any cause of death related to pathology or not) - Safety in terms of technical issues — 12 months
technical issues (any adverse event during stent placement)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| AOU Città della Salute e della Scienza di Torino | Torino | TO | Recruiting |
More University of Turin, Italy trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06325371 on ClinicalTrials.gov ↗ ← All trials in Italy