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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visceral aneurysm stenting | Device | Flow diverter stenting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the stenting in terms of patency and side branches | stent patency and side branches (the absence of stenosis greater than 50% of the stent's internal lumen and the side branches' lumen) | 12 months |
| Efficacy of the stenting in terms of aneurysm thrombosis rate | aneurysm (partial or complete, >50% or 100%) thrombosis | 12 months |
| Efficacy of the stenting in terms of aneurysm volume assessment | aneurysm volume assessment (percentage of volume reduction respect to the initial volume) | 12 months |
| Safety in terms of morbidity | morbidity (any adverse events occured during follow up for any causes and by causes associated with treatment) | 12 months |
| Safety in terms of mortality | mortality (any cause of death related to pathology or not) | 12 months |
| Safety in terms of technical issues | technical issues (any adverse event during stent placement) | 12 months |
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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:
anatomical characteristics compatible with the stent DED Instruction for Use (IFU). Specifically:
proper adherence to the anticoagulant and antiplatelet pharmacological protocol for the peri-procedural and post-procedural periods. Specifically:
Exclusion Criteria:
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Men and women >18 years old with the presence of a visceral aneurysm.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Discalzi, M.D. | Contact | 390116336311 | adiscalzi@cittadellasalute.to.it | |
| Bruno Ficara, Pharm.D. | Contact | 390116336311 | bruno.ficara@unito.it |
| Name | Affiliation | Role |
|---|---|---|
| Marco Calandri, M.D. | University of Torino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Città della Salute e della Scienza di Torino | Recruiting | Torino | TO | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40082273 | Derived | Discalzi A, Nardelli F, Ficara B, Comelli S, de Donato G, Fanelli F, Quaretti P, Sallemi C, Semeraro V, Sirovich R, Calandri M; DEDICATE Investigators. Study Protocol DEDICATE: Italian Multicenter Study on the Treatment of Visceral Aneurysms with the Derivo Peripher and Derivo 2 Flow Diverter Stent. Cardiovasc Intervent Radiol. 2025 May;48(5):694-701. doi: 10.1007/s00270-025-04016-8. Epub 2025 Mar 13. |
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No IPD will be shared to other researchers
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| D001018 |
| Aortic Diseases |