Treatment of visceral aneurysms using flow diversion stents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the treatment of visceral aneurysms using the Derivo Peripher and Derivo 2 flow diversion stents. It involves a multicentric approach with a retrospective analysis of data collected from 100 patients over a 65-month enrollment period. Patients will undergo clinical and radiological evaluations at least 12 months post-intervention to assess the effectiveness of the stenting procedure. The study adheres to established guidelines for the treatment of various types of visceral artery aneurysms.

Why it matters

Who can join: the full rules

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

Where it's running

• AOU Città della Salute e della Scienza di Torino
  Torino, To, Italy Recruiting

Study contacts

• Principal investigator: Marco Calandri, M.D. — University of Torino
• Study coordinator: Andrea Discalzi, M.D.
• Email: adiscalzi@cittadellasalute.to.it
• Phone: 390116336311

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.