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

Recruiting

• Conditions: Aneurysm Abdominal; Arterial Aneurysm

• Registration Number: NCT06325371
• Lead Sponsor: University of Turin, Italy

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-22
• Study Start: 2024-11-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
Efficacy of the stenting in terms of aneurysm thrombosis rate	12 months	aneurysm (partial or complete, \>50% or 100%) thrombosis
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)
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)

Trial Locations

Locations (1)

AOU Città della Salute e della Scienza di Torino; 🇮🇹 Torino, TO, Italy