Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05484115
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2022-07-06
Brief Title:
Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
Randomized Controlled Clinical Trial on the Application of Heli-FX EndoAnchors in Conjunction With the Endurant IIIIs Endograft in Infrarenal Aortic Aneurysms With a Wide Infrarenal Neck HERCULES Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
HERCULES
Brief Summary:
The HERCULES trial is a Randomized controlled clinical trial designed to prospectively compare endosuture aneurysm repair ESAR to standard endovascular aneurysm repair EVAR clinical outcomes in treatment of infrarenal abdominal aortic aneurysm AAA in subjects having wide proximal aortic neck diameters 28mm and 32mm
Detailed Description:
HERCULES is an investigator driven trial and a collaborative research project with Medtronic
Design Prospective post-market global multicenter randomized 11 two-arm superiority trial
Up to 300 subjects will be recruited in up to 40 sites in Europe and the US All subjects shall be followed per local societal guidelines and per the Endurant IIIIs and Heli-FX EndoAnchor instruction for use IFU recommendations for post-implant follow-up and CT-imaging with expected assessments at baseline index procedures 1-month and annually at 1 2 3 4 and 5 years post-index procedure
Devices used in HERCULES include the Endurant IIIIs stent graft system EVAR arm and the Endurant IIIIs stent graft system plus the Heli-FX EndoAnchor System ESAR arm
This study is being conducted to collect clinical evidence from treatment of patients with infrarenal AAA having wide proximal aortic neck diameters 28mm and 32mm comparing clinical outcomes with treatment of the AAA with the Endurant IIIIs stent graft in conjunction with Heli-FX EndoAnchors to treatment of the AAA with the Endurant IIIIs stent graft alone Though both the Endurant IIIIs stent graft and Heli-FX EndoAnchors are commercially approved in this indication clinical evidence comparing these two treatments in patients with wide proximal aortic neck diameters is not currently available Collecting clinical data specific to this patient population including procedure and imaging data as well as long term outcomes will provide a foundation to further characterize the clinical outcomes of treatment for patients with infrarenal AAA with wide proximal aortic neck diameters
Design Prospective post-market global multicenter randomized 11 two-arm superiority trial
Up to 300 subjects will be recruited in up to 40 sites in Europe and the US All subjects shall be followed per local societal guidelines and per the Endurant IIIIs and Heli-FX EndoAnchor instruction for use IFU recommendations for post-implant follow-up and CT-imaging with expected assessments at baseline index procedures 1-month and annually at 1 2 3 4 and 5 years post-index procedure
Devices used in HERCULES include the Endurant IIIIs stent graft system EVAR arm and the Endurant IIIIs stent graft system plus the Heli-FX EndoAnchor System ESAR arm
This study is being conducted to collect clinical evidence from treatment of patients with infrarenal AAA having wide proximal aortic neck diameters 28mm and 32mm comparing clinical outcomes with treatment of the AAA with the Endurant IIIIs stent graft in conjunction with Heli-FX EndoAnchors to treatment of the AAA with the Endurant IIIIs stent graft alone Though both the Endurant IIIIs stent graft and Heli-FX EndoAnchors are commercially approved in this indication clinical evidence comparing these two treatments in patients with wide proximal aortic neck diameters is not currently available Collecting clinical data specific to this patient population including procedure and imaging data as well as long term outcomes will provide a foundation to further characterize the clinical outcomes of treatment for patients with infrarenal AAA with wide proximal aortic neck diameters
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?:
None
Is an FDA AA801 Violation?:
None