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NCT05150873: ReSTHoNe

Anatomical Feasibility of an Off-the-shelf Scalloped Stent-graft for Infrarenal Abdominal Aneurysm With a Hostile Neck

Completed Last updated 6 February 2024
What this trial tests

trial testing CTA evaluation in Aortic Aneurysm in 1,000 participants. Completed in 1 December 2022.

Timeline
1 January 2022
Primary endpoint
1 June 2022
1 December 2022

Quick facts

Lead sponsorAzienda Ospedaliero-Universitaria di Modena
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,000
Start date1 January 2022
Primary completion1 June 2022
Estimated completion1 December 2022
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 Aortic Aneurysm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In clinical practice a lot of EVAR cases are performed IFU for adverse neck anatomy(6) with acceptable short- and mid-term outcomes, but the long-term durability is currently an issue (7). Neck length shorter than 15 mm and angulation are two of. neck charteristics. that contribute more to define an "hostile neck" (8). The issue linked to the anatomical not feasibility of standard EVAR in patients not eligible for OR can be solved with custom made devices (CMD), but they were limited by high production costs and long time for creations (10-12 weeks)1. Nowadays no one off-the-shelf device aimed to overcome neck hostility in AAA is available on the market. The present study aims at evaluating the anatomical applicability of an off-the-shelf scalloped stent-graft to treat infrarenal AAA with a short and/or angulated neck.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Anatomical Feasibility of an Off-the-shelf Single-Renal Scalloped Stent-Graft for Hostile Neck Abdominal Aortic Aneurysm: A Preclinical Study.
    Gennai S, Leone N, Andreoli F, Migliari M, et al · · 2025 · PMID 37096777 · DOI 10.1177/15266028231169164

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Other recruiting trials for Aortic Aneurysm

Currently open trials in the same condition.

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Trials by the same sponsor.

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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/NCT05150873.

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