Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aneurysm Abdominal
- Sponsor
- University of Turin, Italy
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Efficacy of the stenting in terms of aneurysm thrombosis rate
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Efficacy of the stenting in terms of aneurysm thrombosis rate
Time Frame: 12 months
aneurysm (partial or complete, \>50% or 100%) thrombosis
Safety in terms of morbidity
Time Frame: 12 months
morbidity (any adverse events occured during follow up for any causes and by causes associated with treatment)
Safety in terms of mortality
Time Frame: 12 months
mortality (any cause of death related to pathology or not)
Safety in terms of technical issues
Time Frame: 12 months
technical issues (any adverse event during stent placement)
Efficacy of the stenting in terms of patency and side branches
Time Frame: 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 volume assessment
Time Frame: 12 months
aneurysm volume assessment (percentage of volume reduction respect to the initial volume)