Actively Recruiting
Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2
Led by University of Turin, Italy · Updated on 2025-02-18
100
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Diagnosis of visceral artery aneurysms by computed tomography angiography (CTA) with treatment indication per 2020 SVS and 2024 SICVE/SIRM and 2024 CIRSE guidelines
- Renal artery aneurysm larger than 2 cm if fusiform, or any size if saccular or bifurcation morphology, or in fertile women or hypertensive patients with renal stenosis
- Splenic artery aneurysm larger than 2 cm or any size in fertile women
- Celiac tripod aneurysm larger than 2 cm
- Hepatic artery aneurysm larger than 2 cm or growth greater than 0.5 cm per year
- Any size aneurysm in superior mesenteric, gastric, gastroepiploic, pancreaticoduodenal, gastroduodenal, colic, jejunal, and ileal arteries
- Anatomical compatibility with stent device instructions for use, including stent diameter matching the largest proximal or distal vessel diameter with 1-2 mm oversizing
- Stent length allowing for adequate proximal and distal landing, covering the aneurysm neck 2.5 times the vessel's internal diameter and at least 15 mm
- Adherence to anticoagulant and antiplatelet protocol: beginning dual antiplatelet therapy at least 3 days before procedure or with loading dose, systemic anticoagulation during procedure (Heparin 70 IU/kg to ACT > 250 s), and continuation of dual antiplatelet therapy for at least 1 month followed by single antiplatelet therapy indefinitely
You will not qualify if you...
- Hemodynamically unstable patients or those with CT signs of rupture or contained rupture of visceral aneurysm
- Pregnant or breastfeeding women
- Life expectancy less than 2 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
AOU Città della Salute e della Scienza di Torino
Torino, TO, Italy, 10126
Actively Recruiting
Research Team
A
Andrea Discalzi, M.D.
CONTACT
B
Bruno Ficara, Pharm.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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