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NCT Number: NCT06325371

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

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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Key information

Conditions

Aneurysm Abdominal Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Arterial Aneurysm Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Città della Salute e della Scienza di Torino

Torino, TO, 10126, Italy

Location status: Recruiting

Location contact

Andrea Dott. Discalzi, MD

SUB_INVESTIGATOR

Marco Prof. Calandri, MD

CONTACT

[email protected]

+390116336311

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visceral aneurysm stenting

Device

Flow diverter stenting

Other names: stent

Primary outcomes

  1. Efficacy of the stenting in terms of patency and side branches

    Time frame: 12 months

    stent patency and side branches (the absence of stenosis greater than 50% of the stent's internal lumen and the side branches' lumen)

  2. Efficacy of the stenting in terms of aneurysm thrombosis rate

    Time frame: 12 months

    aneurysm (partial or complete, >50% or 100%) thrombosis

  3. Efficacy of the stenting in terms of aneurysm volume assessment

    Time frame: 12 months

    aneurysm volume assessment (percentage of volume reduction respect to the initial volume)

  4. Safety in terms of morbidity

    Time frame: 12 months

    morbidity (any adverse events occured during follow up for any causes and by causes associated with treatment)

  5. Safety in terms of mortality

    Time frame: 12 months

    mortality (any cause of death related to pathology or not)

  6. Safety in terms of technical issues

    Time frame: 12 months

    technical issues (any adverse event during stent placement)

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Discalzi, M.D.

CONTACT

[email protected]

390116336311

Bruno Ficara, Pharm.D.

CONTACT

[email protected]

390116336311

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Acronym: DEDICATE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 22, 2024
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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