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

Aneurysm Abdominal Clinical Trial

— DEDICATE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06325371
• Other study ID #: 0028201
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: University of Turin, Italy
• Contact: Andrea Discalzi, M.D.
• Phone: 390116336311
• Email: adiscalzi[@]cittadellasalute.to.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 54 months (01/01/2020-30/06/2024). Minimum sample size will be of 50 Patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years old

• Visceral aneurysms or pseudoaneurysms without signs of rupture, evaluated with angio-CT, with indication for treatment according to the guidelines of the Society of Vascular Surgery (2020), the European Society of Vascular Surgery (2017), and the Italian Society of Vascular Surgery (2016). 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, or all pseudoaneurysms regardless of size.

• Splenic artery: if > 2 cm, or all dimensions in fertile women, or all pseudoaneurysms regardless of size.

• Celiac tripod: if > 2 cm, or all pseudoaneurysms regardless of size.

• Hepatic artery: if > 2 cm or growth greater than 0.5 cm/year, or all pseudoaneurysms regardless of size.

• 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 Instruction for Use (IFU) of the DED stent.

Exclusion Criteria:

• Hemodynamically unstable patients or those with CT signs of visceral aneurysm rupture or contained rupture

• Pregnant or breastfeeding women

• Life expectancy of less than 2 years

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Abdominal
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Visceral aneurysm stenting
Flow diverter stenting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Efficacy of the stenting in terms of aneurysm thrombosis rate	aneurysm (partial or complete, >50% or 100%) thrombosis	12 months
Primary	Efficacy of the stenting in terms of aneurysm volume assessment	aneurysm volume assessment (percentage of volume reduction respect to the initial volume)	12 months
Primary	Safety in terms of morbidity	morbidity (any adverse events occured during follow up for any causes and by causes associated with treatment)	12 months
Primary	Safety in terms of mortality	mortality (any cause of death related to pathology or not)	12 months
Primary	Safety in terms of technical issues	technical issues (any adverse event during stent placement)	12 months