Clinical trial NCT06325371: Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2
Official title: Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aneurysm Abdominal
Arterial Aneurysm
Keywords: flow diverter
visceral aneurysm
stenting
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women \>18 years old with the presence of a visceral aneurysm.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of the stenting in terms of patency and side branches
timeFrame: 12 months
measure: Efficacy of the stenting in terms of aneurysm thrombosis rate
timeFrame: 12 months
measure: Efficacy of the stenting in terms of aneurysm volume assessment
timeFrame: 12 months
measure: Safety in terms of morbidity
timeFrame: 12 months
measure: Safety in terms of mortality
timeFrame: 12 months
measure: Safety in terms of technical issues
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino
state: TO
Study officials:
affiliation: University of Torino
name: Marco Calandri, M.D.
role: PRINCIPAL_INVESTIGATOR
References: