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CardioVascular and Interventional Radiology

13.03.2025 | STUDY PROTOCOL

Study Protocol DEDICATE: Italian Multicenter Study on the Treatment of Visceral Aneurysms with the Derivo Peripher and Derivo 2 Flow Diverter Stent

verfasst von: Andrea Discalzi, Floriana Nardelli, Bruno Ficara, Simone Comelli, Gianmarco de Donato, Fabrizio Fanelli, Pietro Quaretti, Claudio Sallemi, Vittorio Semeraro, Roberta Sirovich, Marco Calandri, on behalf of DEDICATE Investigators

Erschienen in: CardioVascular and Interventional Radiology

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Abstract

Purpose

This study aims to evaluate the safety and efficacy of the Derivo peripher and Derivo 2 Embolization Device Flow Diverter Stents (DEDs, Acandis GmbH) in treating visceral aneurysms.

Materials and Methods

This multicentric registry with core-lab evaluation involves 29 Italian Interventional Radiology and Vascular Surgery units, targeting 100 patients. Inclusion criteria include visceral artery aneurysms without signs of rupture and adherence to correct DED stent sizing and anticoagulant and antiplatelet protocols. Patients will undergo physical examination and computed tomography angiography (CTA) within 6-month and at 1-year post-procedure. A core laboratory will evaluate all pre- and post-procedure CTA and procedural angiographic images for procedural correctness (adherence to correct DED sizing, deployment accuracy, and technical issues), stent morphology during follow-up (patency and geometrical changes), and VAA morphological changes (volume variation, thrombosis grade, and number of patent branches). The primary objective is to evaluate the technical efficacy and safety of DEDs at 1-year follow-up. Efficacy will be assessed by patency of DEDs and side branches, aneurysm thrombosis (< 50%, > 50% or total volume of the aneurysm), and non-increase in aneurysm volume (percentage change relative to initial volume). Safety will be assessed by morbidity (adverse events during follow-up), mortality (any cause of death), and technical issues (adverse events during stent placement, based on CIRSE classification of complications).

Expected Gain of Knowledge

The DEDICATE registry will provide further information on the effectiveness of flow-diverting stents in treating visceral aneurysmal pathology.

Trial Registration ClinicalTrials.gov identifier: NCT06325371.

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Titel: Study Protocol DEDICATE: Italian Multicenter Study on the Treatment of Visceral Aneurysms with the Derivo Peripher and Derivo 2 Flow Diverter Stent
verfasst von: Andrea Discalzi
Floriana Nardelli
Bruno Ficara
Simone Comelli
Gianmarco de Donato
Fabrizio Fanelli
Pietro Quaretti
Claudio Sallemi
Vittorio Semeraro
Roberta Sirovich
Marco Calandri
on behalf of DEDICATE Investigators
Publikationsdatum: 13.03.2025
Verlag: Springer US
Erschienen in: CardioVascular and Interventional Radiology
Print ISSN: 0174-1551
Elektronische ISSN: 1432-086X
DOI: https://doi.org/10.1007/s00270-025-04016-8

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