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Recruiting NCT06325371

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

— Observational Aneurysm Abdominal Arterial Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Visceral aneurysm stenting.
Who it may be relevant to
Registry conditions: Aneurysm Abdominal, Arterial Aneurysm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Visceral aneurysm stenting
    Flow diverter stenting

Primary outcome measures

  • Efficacy of the stenting in terms of patency and side branches [Time frame: 12 months]
  • Efficacy of the stenting in terms of aneurysm thrombosis rate [Time frame: 12 months]
  • Efficacy of the stenting in terms of aneurysm volume assessment [Time frame: 12 months]
  • Safety in terms of morbidity [Time frame: 12 months]
  • Safety in terms of mortality [Time frame: 12 months]
  • Safety in terms of technical issues [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • >18 years old
  • Visceral artery aneurysms, evaluated with computed tomography angiography-CTA- withindication for treatment according to 2020 SVS and 2024 SICVE/SIRM and 2024 CIRSE guidelines. Specifically:
  • Renal artery: >2 cm if fusiform morphology or all dimensions if sacculary or bifurcation morphology, if in fertile women or in hypertensive patients with renal stenosis
  • Splenic artery: if >2 cm, or all dimensions in fertile women.
  • Celiac tripod: if >2 cm.
  • Hepatic artery: if >2 cm or growth greater than 0.5 cm/year.
  • Superior mesenteric artery, gastric or gastroepiploic artery, pancreaticoduodenal or gastroduodenal arteries, colic arteries, jejunal arteries, and ileal arteries: any size
  • anatomical characteristics compatible with the stent DED Instruction for Use (IFU). Specifically:
  • the stent diameter should match the largest diameter of either the proximal or distal vessel of the aneurysm with an oversizing of 1-2 mm according to IFU.
  • the stent length must allow for adequate proximal and distal landing, covering the neck of the aneurysm to 2.5 times the vessel's internal diameter and no less than 15 mm.
  • proper adherence to the anticoagulant and antiplatelet pharmacological protocol for the peri-procedural and post-procedural periods. Specifically:
  • all patients should begin dual antiplatelet therapy (DAPT) before surgery (for at least 3 days before the procedure or with a loading dose pre-procedurally).
  • all patients receive systemic anticoagulation during the procedure (Heparin 70 IU/kg to achieve an Activated Clot Time (ACT) > 250 s).
  • after the procedure, the patient should continue DAPT (e.g., ASA 100 mg daily and Clopidogrel 75 mg daily) for at least 1 month, then continue with single antiplatelet therapy (e.g., ASA 100 mg) indefinitely.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • AOU Città della Salute e della Scienza di Torino — Torino

Publications

  • Discalzi A, Nardelli F, Ficara B, Comelli S, de Donato G, Fanelli F, Quaretti P, Sallemi C, Semeraro V, Sirovich R, Calandri M; DEDICATE Investigators. Study Protocol DEDICATE: Italian Multicenter Study on the Treatment of Visceral Aneurysms with the Derivo Peripher and Derivo 2 Flow Diverter Stent. Cardiovasc Intervent Radiol. 2025 May;48(5):694-701. doi: 10.1007/s00270-025-04016-8. Epub 2025 Mar PMID 40082273

Identifiers

NCT: NCT06325371 · 0028201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗