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

Launched by UNIVERSITY OF TURIN, ITALY · Mar 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special medical device called the flow diversion stent (Derivo Peripher and Derivo 2) to treat visceral aneurysms, which are abnormal bulges in blood vessels located in the abdomen. The trial involves gathering information from 100 patients over a period of about 5 years, starting from January 2020. Participants will be monitored for at least 12 months after their treatment, with regular check-ups that include scans to see how well the stent is working.

To be eligible for the trial, patients need to be over 18 years old and have specific types of aneurysms that are not ruptured. Some examples are aneurysms in the renal artery (the blood vessel supplying the kidneys) or splenic artery (the blood vessel supplying the spleen) that meet certain size criteria. Patients must also be able to follow a specific medication plan before and after the procedure. However, those who are very ill, pregnant, or have a life expectancy of less than 2 years cannot participate. Overall, this trial aims to gather valuable data to help improve treatment options for patients with these serious conditions.

Gender

ALL

Eligibility criteria

• 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