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

University of Turin

Status: Enrolling

Conditions: Aneurysm Abdominal; Arterial Aneurysm

Treatments: Device: Visceral aneurysm stenting

Study type: Observational

Funder types: Other

Identifiers

NCT06325371

0028201

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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