Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05150873
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2021-11-25
Brief Title:
Anatomical Feasibility of an Off-the-shelf Scalloped Stent-graft for Infrarenal Abdominal Aneurysm With a Hostile Neck
Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Organization:
Azienda Ospedaliero-Universitaria di Modena
Study Overview
Official Title:
Anatomical Feasibility of an Off-the-shelf Scalloped Stent-graft for Infrarenal Abdominal Aneurysm With a Hostile Neck ReSTHoNe Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReSTHoNe
Brief Summary:
In clinical practice a lot of EVAR cases are performed IFU for adverse neck anatomy6 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 weeks1 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 andor angulated neck
The present study aims at evaluating the anatomical applicability of an off-the-shelf scalloped stent-graft to treat infrarenal AAA with a short andor angulated neck
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 anatomy3-5 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 weeks1 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 andor 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
The present study aims at evaluating the anatomical applicability of an off-the-shelf scalloped stent graft to treat infrarenal AAA with a short andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None