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

NCT06325371 | Recruiting DMC FDA Device

• 1 other identifier: 0028201
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Aneurysm Abdominal; Arterial Aneurysm

Keywords

flow diverter; visceral aneurysm; stenting

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

Visceral aneurysm stenting DEVICE

Flow diverter stenting

Also known as: stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women \>18 years old with the presence of a visceral aneurysm.

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

AOU Città della Salute e della Scienza di Torino

Torino, TO, 10126, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 40082273 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Stents

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Marco Calandri, M.D.

  University of Torino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Discalzi, M.D.

CONTACT

390116336311; adiscalzi@cittadellasalute.to.it

Bruno Ficara, Pharm.D.

CONTACT

390116336311; bruno.ficara@unito.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 22, 2024
• Study Start: November 20, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)