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Purpose <p>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.</p> Materials and Methods <p>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 (&lt; 50%, &gt; 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).</p> Expected Gain of Knowledge <p>The DEDICATE registry will provide further information on the effectiveness of flow-diverting stents in treating visceral aneurysmal pathology.</p> <p><i>Trial Registration ClinicalTrials.gov identifier</i>: NCT06325371.</p>

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

  • 期刊论文

  • 发表日期：

    2025年3月13日

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  • Andrea Discalzi,
  • Floriana Nardelli,
  • Bruno Ficara,
  • Simone Comelli,
  • Gianmarco de Donato,
  • Fabrizio Fanelli,
  • Pietro Quaretti,
  • Claudio Sallemi,
  • Vittorio Semeraro,
  • Roberta Sirovich,
  • Marco Calandri,
  • Massimiliano Allegritti,
  • Roberto Arpesani,
  • Mario Beghetto,
  • Alessandro Beleú,
  • Alessandro Beneventi,
  • Luca Boi,
  • Matteo Cappucci,
  • Andrea Casadei,
  • Fabrizio Chegai,
  • Fabrizio Coi,
  • Mario Corona,
  • Andrea Doriguzzi Breatta,
  • Francesco Di Bartolomeo,
  • Enrico Epifani,
  • Stefano Fazzini,
  • Anna Maria Ierardi,
  • Andrea Mancini,
  • Silvio Maresca,
  • Diego Moniaci,
  • Lorenzo Paolo Moramarco,
  • Pierluigi Muratore,
  • Enrico Pampana,
  • Domenico Patanè,
  • Giuseppe Pelle,
  • Denis Rossato,
  • Marco Solcia,
  • Carmelo Stanca,
  • Mario Vallone

摘要

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.