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Multicenter Study
. 2025 May;48(5):694-701.
doi: 10.1007/s00270-025-04016-8. Epub 2025 Mar 13.

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

Andrea Discalzi  1 , Floriana Nardelli  2 , Bruno Ficara  3 , Simone Comelli  4 , Gianmarco de Donato  5 , Fabrizio Fanelli  6 , Pietro Quaretti  7 , Claudio Sallemi  8 , Vittorio Semeraro  9 , Roberta Sirovich  10 , Marco Calandri  3 ; DEDICATE Investigators
Collaborators, Affiliations
Multicenter Study

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

Andrea Discalzi et al. Cardiovasc Intervent Radiol. 2025 May.

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.

Keywords: Embolization; Endovascular therapy; Flow diverter stent; Visceral artery aneurysms.

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Conflict of interest statement

Declarations. Conflict of interest: The authors declare that they have no conflict of interest. Consent for Publication: For this type of study, consent for publication is not required. Human and Animal Rights: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed Consent: Informed consent will be obtained from all individual participants included in the study.

References

    1. Chaer RA, Abularrage CJ, Coleman DM, Eslami MH, Kashyap VS, Rockman C, Murad MH. The Society for Vascular Surgery clinical practice guidelines on the management of visceral aneurysms. J Vasc Surg. 2020;72(1S):3S-39S. https://doi.org/10.1016/j.jvs.2020.01.039 . - DOI - PubMed
    1. Pratesi C, Esposito D, Martini R, Novali C, Zaninelli A, Annese AL, Baggi P, Bellosta R, Bianchini Massoni C, Bonardelli S, Carriero S, Cervelli R, Chisci E, Cioni R, Corvino F, Cobelli F, Fanelli F, Fargion AT, Femia M, Freyrie A, Gaggiano A, Gallitto E, Gennai S, Giampalma E, Giurazza F, Grego F, Guazzarotti G, Ierardi AM, Kahlberg AL, Mascia D, Mezzetto L, Michelagnoli S, Nardelli F, Niola R, Lenti M, Perrone O, Piacentino F, Piffaretti G, Pulli R, Puntel G, Puppini G, Rossato D, Rossi M, Silingardi R, Sirignano P, Squizzato F, Tipaldi MA, Venturini M, Veraldi GF, Vizzuso A, Allievi S, Attisani L, Fino G, Ghirardini F, Manzo P, Migliari M, Steidler S, Miele V, Taurino M, Orso M, Cariati M. Italian Guidelines for Vascular and Endovascular Surgery Collaborators. Guidelines on the diagnosis, treatment and management of visceral and renal arteries aneurysms: a joint assessment by the Italian Societies of Vascular and Endovascular Surgery (SICVE) and Medical and Interventional Radiology (SIRM). J Cardiovasc Surg. 2024;65(1):49–63. https://doi.org/10.23736/S0021-9509.23.12809-6 . - DOI
    1. Rossi M, Krokidis M, Kashef E, Peynircioglu B, Tipaldi MA. CIRSE standards of practice for the endovascular treatment of visceral and renal artery aneurysms and pseudoaneurysms. Cardiovasc Intervent Radiol. 2024;47(1):26–35. https://doi.org/10.1007/s00270-023-03620-w . - DOI - PubMed
    1. Venturini M, Piacentino F, Coppola A, Bettoni V, Macchi E, De Marchi G, Curti M, Ossola C, Marra P, Palmisano A, Cappelli A, Basile A, Golfieri R, Cobelli F, Piffaretti G, Tozzi M, Carcano G, Fontana F. Visceral artery aneurysms embolization and other interventional options: state of the art and new perspectives. J Clin Med. 2021;10(11):2520. https://doi.org/10.3390/jcm10112520 . - DOI - PubMed - PMC
    1. Venturini M, Marra P, Colombo M, Alparone M, Agostini G, Bertoglio L, Sallemi C, Salvioni M, Gusmini S, Balzano G, Castellano R, Aldrighetti L, Tshomba Y, Falconi M, Melissano G, De Cobelli F, Chiesa R, Del Maschio A. Endovascular treatment of visceral artery aneurysms and pseudoaneurysms in 100 patients: covered stenting vs transcatheter embolization. J Endovasc Ther. 2017;24(5):709–17. https://doi.org/10.1177/1526602817717715 . - DOI - PubMed

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