Treatment of visceral aneurysms using flow diversion stents
Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2
This study is testing if using special stents can safely treat visceral aneurysms in patients and help improve their health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Turin, Italy Academic / other |
| Locations | 1 site (Torino, TO) |
| Trial ID | NCT06325371 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with specific types of visceral artery aneurysms that meet treatment criteria outlined in current medical guidelines.
Not a fit: Patients with aneurysms that do not meet the specified size or morphological criteria for stenting may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with visceral aneurysms, potentially reducing complications and improving quality of life.
How similar studies have performed: While this approach is based on established techniques, the specific use of the Derivo stents in this context is being evaluated for the first time in a multicentric observational setting.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Torino, TO
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.