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Endovascular Repair
EVAR vs ESAR for Abdominal Aortic Aneurysm (HERCULES Trial)
N/A
Recruiting
Led By MMPJ Reijnen, Prof
Research Sponsored by Rijnstate Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Infrarenal neck diameter ≥ 28 mm and ≤32 mm
Must not have
Patient with eGFR < 30 ml/min/1.73m2 before the intervention
Patient is not eligible for standard EVAR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two methods of repairing abdominal aortic aneurysms in patients with wide aortic necks. One method uses a stent graft alone, while the other adds extra anchors to secure the graft. The goal is to see which method works better for these patients.
Who is the study for?
This trial is for adults with abdominal aortic aneurysms that have a neck diameter of 28-32mm and are at least 10mm long. Candidates must need elective repair, fit the device guidelines, and not have had recent severe cardiovascular events or other conditions that could affect results or increase risks.
What is being tested?
The HERCULES trial compares two procedures for repairing infrarenal abdominal aortic aneurysms: EVAR using Endurant II/IIs stent grafts versus ESAR with Heli-FX EndoAnchor system. It's randomized, meaning patients are put into groups by chance to test which method works better.
What are the potential side effects?
Potential side effects may include complications related to the implantation procedure such as infection risk, bleeding disorders, allergic reactions to device materials, and possible impact on kidney function due to contrast media used during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
The part of my aorta just above my kidneys is between 28 and 32 mm wide.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is low, with an eGFR below 30.
Select...
I am not a candidate for standard EVAR treatment.
Select...
I have a ruptured or infected aneurysm.
Select...
I have a bleeding disorder that is not under control.
Select...
I have had a stroke or heart attack in the last 3 months.
Select...
I am currently pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite endpoint at on proximal seal outcomes
Secondary study objectives
Freedom from aneurysm sac growth
Freedom from migration
Freedom from neck dilatation ≥ 3 mm
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft systemActive Control1 Intervention
Group II: Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with EndoanchorsActive Control1 Intervention
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Abdominal Aortic Aneurysm (AAA) include open surgical repair and endovascular aneurysm repair (EVAR). Open surgical repair involves a large incision to directly access and replace the aneurysmal section of the aorta with a synthetic graft.
EVAR, on the other hand, is a minimally invasive procedure where a stent-graft is inserted through the femoral artery and positioned within the aneurysm to reinforce the aortic wall. Endosuture Aneurysm Repair (ESAR) is a variation of EVAR that uses sutures to secure the endograft to the aortic wall, providing additional stability and potentially reducing the risk of graft migration and endoleaks.
Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, considering factors like recovery time, risks, and long-term outcomes.
Find a Location
Who is running the clinical trial?
MedtronicIndustry Sponsor
619 Previous Clinical Trials
763,788 Total Patients Enrolled
Rijnstate HospitalLead Sponsor
189 Previous Clinical Trials
75,013 Total Patients Enrolled
MMPJ Reijnen, ProfPrincipal InvestigatorRijnstate, Arnhem, the Netherlands
1 Previous Clinical Trials
1,000 Total Patients Enrolled
K. Donas, ProfPrincipal InvestigatorAsklepios Clinic Langen, Langen, Germany