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

NCT05150873 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-02-06

No results posted yet for this study

Summary

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.

Conditions

  • Aortic Aneurysm

Interventions

OTHER

CTA evaluation

Any pre-operattive CTA of the patients of the cohort will be carefully evaluated to determine the theoric anatomical feasibility of an off the shelf Endograft, particularly in patients with an angulated and short aortic neck

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria di Modena

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-06-01
Completion
2022-12-01

Countries

  • Italy

Study Locations

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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 NCT05150873 on ClinicalTrials.gov