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NCT05609539: RESTHONE

Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm

Completed Last updated 2 October 2025
What this trial tests

trial testing Endovascular Aortic Repair (EVAR) in Abdominal Aortic Aneurysm in 50 participants. Completed in 28 September 2025.

Timeline
1 February 2023
Primary endpoint
28 September 2025
28 September 2025

Quick facts

Lead sponsorAzienda Ospedaliero-Universitaria di Modena
StatusCompleted
Study typeOBSERVATIONAL
Enrollment50
Start date1 February 2023
Primary completion28 September 2025
Estimated completion28 September 2025
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Azienda Ospedaliero-Universitaria di Modena — full company profile →

Who can join

18 and older, any sex, with Abdominal Aortic Aneurysm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this multicenter, observational cohort study is to evaluates the clinical effectiveness of a single-renal scallop custom-made stent-graft (TREO, Terumo Aortic, Sunrise, FL) to treat "hostile" AAA with mismatched renal arteries as actual standard of care in this Vascular Unit The main question it aims to answer are: if a dedicated devices could improve the results in the endovascular treatment of patients suffering to infrarenal abdominal aortic aneurism with a mismatched takeoff of the renal arteries. Participants responding to inclusion criteria will be treated as best clinical practice with a custom made device with a single scallop for the renal artery. The minimum follow-up requested, as standard clinical practice, was: 3-months, 12-18 months- and 5-years CTA; clinical and DUS examination at 6- and 12- and 36-months after the intervention and yearly thereafter. No comparison group was present.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Endovascular Aortic Repair (EVAR)

Trials testing the same drug.

Other recruiting trials for Abdominal Aortic Aneurysm

Currently open trials in the same condition.

Other Azienda Ospedaliero-Universitaria di Modena trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05609539.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing