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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

Sponsor: University of Turin, Italy

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-11-20

Completion Date

2026-06-30

Last Updated

2025-02-18

Healthy Volunteers

Conditions

Aneurysm Abdominal Arterial Aneurysm

Interventions

DEVICE

Visceral aneurysm stenting

Flow diverter stenting

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

Locations (1)

AOU Città della Salute e della Scienza di Torino

Torino, TO, Italy