Aneurysm Abdominal, Arterial Aneurysm
Conditions
Keywords
flow diverter, visceral aneurysm, stenting
Brief 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.
Interventions
DEVICEVisceral aneurysm stenting
Flow diverter stenting
Sponsors
University of Turin, Italy
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Italy
Contacts
Primary ContactAndrea Discalzi, M.D.
Backup ContactBruno Ficara, Pharm.D.
Outcome results
None listed