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Recruiting Observational

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

NCT06325371 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-11-20
Last updated
2025-02-18

Condition(s) studied

Aneurysm AbdominalArterial Aneurysm

Investigational drug(s) / intervention(s)

Visceral aneurysm stenting

Visceral aneurysm stenting: Flow diverter stenting

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
AOU Città della Salute e della Scienza di Torino Torino TO Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06325371 on ClinicalTrials.gov ↗ ← All trials in Italy