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

Обзор

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.

Вмешательства

• Устройство Visceral aneurysm stenting
  Flow diverter stenting

Первичные конечные точки

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

Критерии участия

Критерии включения

• >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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• AOU Città della Salute e della Scienza di Torino — Torino

Публикации

• 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

Идентификаторы

NCT: NCT06325371 · 0028201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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