Ignite Creation Date:
2024-05-06 @ 6:16 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05609539
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2022-10-31
Brief Title:
Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm
Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Organization:
Azienda Ospedaliero-Universitaria di Modena
Study Overview
Official Title:
Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm Clinical Pivotal Trial
Status:
RECRUITING
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:
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
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
Detailed Description:
Endovascular aneurysm repair EVAR is currently the preferred choice to treat the abdominal aortic aneurysms AAA with a feasible anatomy However approximately 40-60 of AAA patients presented unfavorable characteristics for EVAR mainly due to a hostile neck anatomy In real-world clinical practice up to 44 of EVAR cases are performed outside Instruction For Use IFU for an adverse neck anatomy6 Short 15-mm angulated 60 and wide 28-mm aortic necks are the main features concurring to the proximal HNA
The recourse to standard EVAR is currently routine for patients who are not eligible for OR with acceptable short- and mid-term outcomes but the long-term durability of EVAR depends on maintaining proper sealing between the endograft and the aortic neck as well as the iliac arteries HNAs demonstrated worse results when compared to favorable ones in terms of technical success 94 vs 98 and type-Ia endoleak rate 10 vs 2 The issue linked to an unfavorable anatomy can be addressed with more complex techniques but these are limited by high production costs and considerable complexity
TREO Terumo Aortic Inchinnan Renfrewshire UK formerly Treovance Bolton Medical Sunrise Fla is a standard bifurcated modular stent-graft that has shown compelling early- and mid-term results It seems clear that several physicians are still looking for a feasible solution for HNA patients to keep the complexity of the procedure comparable to standard EVAR while yielding improved results
Moreover there is a lack of publications addressing the issue of mismatched take-off of the renal arteries RAs This morphology seems to influence the sealing length and could justify the introduction of dedicated devices A recent study from our group currently under review for publication demonstrated that 25 of patients eligible for EVAR presented with mismatched RAs and that a dedicated device could improve sealing significantly The study group sealing zones length increased by about 25 when applying a hypothetical prototype with a single 10x10mm wide x high renal scallop The same approach could be applied to the sealing surface with similar results In the light of obtained results in selected patients the use of a single renal-scallop custom-made device has been our standard of care
The results will demonstrate whether the supra mentioned graft can the treatment of AAA with mismatched RAs in the real world The effectiveness will be evaluated in terms of technical and clinical success
The benefits could be relevant for the patients in terms of reduction of procedure-related adverse events such as endoleaks and related re-interventions Furthermore the use of custom-made standardized devices could significantly reduce costs for health care providers and in the future it could be the base for an off-the-shelf endograft Procedure-related complications were expected to be similar to standard EVAR and reduced in comparison with literature reporting adverse events in more complex techniques
The present study aims to evaluate the clinical effectiveness of the custom-made standardized single renal scalloped stent-graft Treo Terumo Aortic to treat infrarenal AAA The final objective will be to employ the data obtained in this cohort for a future eventual development of an off-the-shelf device dedicated to patients with mismatched renal arteries Such an endograft could keep the complexity of the procedure as similar as possible to standard EVAR while improving sealing
The recourse to standard EVAR is currently routine for patients who are not eligible for OR with acceptable short- and mid-term outcomes but the long-term durability of EVAR depends on maintaining proper sealing between the endograft and the aortic neck as well as the iliac arteries HNAs demonstrated worse results when compared to favorable ones in terms of technical success 94 vs 98 and type-Ia endoleak rate 10 vs 2 The issue linked to an unfavorable anatomy can be addressed with more complex techniques but these are limited by high production costs and considerable complexity
TREO Terumo Aortic Inchinnan Renfrewshire UK formerly Treovance Bolton Medical Sunrise Fla is a standard bifurcated modular stent-graft that has shown compelling early- and mid-term results It seems clear that several physicians are still looking for a feasible solution for HNA patients to keep the complexity of the procedure comparable to standard EVAR while yielding improved results
Moreover there is a lack of publications addressing the issue of mismatched take-off of the renal arteries RAs This morphology seems to influence the sealing length and could justify the introduction of dedicated devices A recent study from our group currently under review for publication demonstrated that 25 of patients eligible for EVAR presented with mismatched RAs and that a dedicated device could improve sealing significantly The study group sealing zones length increased by about 25 when applying a hypothetical prototype with a single 10x10mm wide x high renal scallop The same approach could be applied to the sealing surface with similar results In the light of obtained results in selected patients the use of a single renal-scallop custom-made device has been our standard of care
The results will demonstrate whether the supra mentioned graft can the treatment of AAA with mismatched RAs in the real world The effectiveness will be evaluated in terms of technical and clinical success
The benefits could be relevant for the patients in terms of reduction of procedure-related adverse events such as endoleaks and related re-interventions Furthermore the use of custom-made standardized devices could significantly reduce costs for health care providers and in the future it could be the base for an off-the-shelf endograft Procedure-related complications were expected to be similar to standard EVAR and reduced in comparison with literature reporting adverse events in more complex techniques
The present study aims to evaluate the clinical effectiveness of the custom-made standardized single renal scalloped stent-graft Treo Terumo Aortic to treat infrarenal AAA The final objective will be to employ the data obtained in this cohort for a future eventual development of an off-the-shelf device dedicated to patients with mismatched renal arteries Such an endograft could keep the complexity of the procedure as similar as possible to standard EVAR while improving sealing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None