MedTrace Logo

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

NCT05609539 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-10-02

No results posted yet for this study

Summary

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.

Conditions

  • Abdominal Aortic Aneurysm

Interventions

DEVICE

Endovascular Aortic Repair (EVAR)

Techniques for delivery and deployment of the standard device have been well described by different papers, but for the "prototype" some attention is required. Once the device was advanced at the level of the lowest RA the C-Arm has been moved to correct the parallax effect and positioned orthogonally to the origin of the artery. This procedure permits perfectly matching the scallop with the artery takeoff. A selective angiogram was performed to assure the patency of the lower RA. After the deployment of the main body proper iliac extensions were delivered to completely exclude the aneurysm as standard practice.

Sponsors & Collaborators

  • Ospedale di Circolo - Fondazione Macchi

    collaborator OTHER

  • Azienda Ospedaliera di Padova

    collaborator OTHER

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    collaborator OTHER

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    collaborator OTHER

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria di Modena

    lead OTHER

Principal Investigators

  • Roberto Silingardi, Prof. · AOU di Modena

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2025-09-28
Completion
2025-09-28
FDA Device
Yes

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05609539 on ClinicalTrials.gov