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

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.

Study Overview

• Status: Recruiting
• Conditions: Aneurysm Abdominal; Arterial Aneurysm
• Intervention / Treatment: Device: Visceral aneurysm stenting

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Andrea Discalzi, M.D.; Phone Number: 390116336311; Email: adiscalzi@cittadellasalute.to.it
• Study Contact Backup: Name: Bruno Ficara, Pharm.D.; Phone Number: 390116336311; Email: bruno.ficara@unito.it

Study Locations

• Italy
  • TO
    • Torino, TO, Italy, 10126
      • Recruiting
      • AOU Città della Salute e della Scienza di Torino
      • Contact: Marco Prof. Calandri, MD; Phone Number: +390116336311; Email: marco.calandri@unito.it
      • Sub-Investigator: Andrea Dott. Discalzi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Investigators: Principal Investigator: Marco Calandri, M.D., University of Torino

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: stenting; flow diverter; visceral aneurysm
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Aneurysm; Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 0028201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No