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

February 4, 2024 updated by: Roberto Silingardi, MD, Azienda Ospedaliero-Universitaria di Modena

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endovascular aneurysm repair (EVAR) is currently accepted as the preferred choice to treat abdominal aortic aneurysms (AAA) with feasible anatomy. Although approximately 40-60% of AAA patients are not considered anatomically feasible for EVAR, mainly in reason of a "hostile neck anatomy". In ''real-world'' clinical practice, up to 44% of EVAR cases are performed outside Instruction For Use (IFU) for adverse neck anatomy. The off-label use of standard EVAR is currently used for patients who are not eligible for OR, with acceptable short- and mid-term outcomes, Endovascular aneurysm repair (EVAR) is currently accepted as the preferred choice to treat the abdominal aortic aneurysms (AAA) with feasible anatomy. Although approximately 40-60% of AAA patients are not considered anatomically feasible for EVAR, mainly in reason of a "hostile neck anatomy"3-5. In ''real-world'' clinical practice, up to 44% of EVAR cases are performed outside Instruction For Use (IFU) for adverse neck anatomy. The off-label use of standard EVAR is currently used for patients who are not eligible for OR, with acceptable short- and mid-term outcomes, but the long-term durability of EVAR depends on the maintenance of the seal between the endograft and the aortic neck as well as the iliac arteries. Some aortic neck characteristics contribute to the definition of ''hostile neck,'' particularly length shorter than 15 mm and angulation among others. From a recent Consensus Conference, the influence of each characteristic on early or late EVAR failure is not clear, but hostile neck morphology is generally associated with higher rates of aneurysm-related adverse events and mortality. A recent independent Expert Panel, applying the Delphi methodology Indeed, agreed to define 10 mm as the threshold value below which standard EVAR should not be considered feasible. Moreover, the same experts agreed on the fact that an angulation above 60° is considered a hostile criterion for EVAR procedure. Finally should be considered that some "hostility" factors can be present at the same time and create the ideal condition for EVAR failure. The issue linked to the anatomical not the 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. From an informal review of some CTA of patients treated with EVAR or OR in mentioned unit, the authors found that more the 20% presented a distance between the two renal arteries more than 5mm. The idea of an "off-the-shelf" graft with a single scallop theoretically had to permit to gain some length along the aortic neck. Furthermore also in the case of angulation, a single scallop theoretically reduced the risk of bird beck and gutter. The aim of the study is to evaluate if a single scalloped "off-the-shelf" stent graft could be appliable and feasible in an adequate number of patients.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Modena
      • Baggiovara, Modena, Italy, 411266
        • AOU di Modena, OCB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients affected by AAAs and electively treated with EVAR or OR in the Vascular Surgery Unit of Modena e Reggio Emilia from 2010 to 2020 were considered eligible for the ex-vivo feasibility study. Mandatory condittion for tthhe enrollemnt is an available 2.5mm CTA.

Description

Inclusion Criteria:

  • Patients Electively treated with EVAR or AAA at the coordinator center
  • Age >18
  • Both sex
  • Preoperative 2.5mm CTA available
  • Written informed consent.

Exclusion Criteria:

  • All. patients not fulfilling the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients ttreatted for AAA
Patients affected by AAA and treated att our institution with EVAR and/or Open Repair between 2010 and 2020
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomica feasibility and applicability of an "off-the-shelf" scallopped stent-graft measured mesured fitting three device model with data recorded from CTA of patients with AAA treted in our unit
Time Frame: 6-months
observational study on the anatomical applicability in the coordinator center of an off-the-shelf scalloped device to treat infrarenal AAA with short and/or angulated neck. 3 different endograft designs were constructed. The preoperative measurements were made according to a previously described methodology. The models were matched with each preoperative CTA measure in order to evaluate if they fit or not in the index patients.
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Modena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

December 8, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3499

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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