What side effects are associated with this type of intervention?

Common side effects of treatments for Abdominal Aortic Aneurysm (AAA), such as Endosuture Aneurysm Repair (ESAR) and standard Endovascular Aneurysm Repair (EVAR), include endoleaks, graft migration, and potential graft infection. Other risks involve damage to surrounding blood vessels, kidney complications from contrast dye, and general surgical risks like bleeding and infection. ESAR, which uses sutures to secure the endograft, may also have specific risks related to suture breakage or failure, potentially leading to graft instability.

What prior FDA approvals exist?

The FDA has approved several endovascular treatments for Abdominal Aortic Aneurysm (AAA), including standard Endovascular Aneurysm Repair (EVAR) devices. These devices typically involve the placement of a stent graft within the aorta to exclude the aneurysm from blood flow. While traditional EVAR relies on the radial force of the stent to secure the graft, newer techniques like Endosuture Aneurysm Repair (ESAR) use sutures to anchor the endograft to the aortic wall, potentially offering improved stability. Specific FDA-approved devices for EVAR include the Gore Excluder, Medtronic Endurant, and Cook Zenith, among others. These devices have been shown to be effective in reducing the risk of aneurysm rupture and improving patient outcomes.

What other types of research exist?

Promising, novel alternatives to Endosuture Aneurysm Repair (ESAR) for Abdominal Aortic Aneurysm (AAA) patients include: 1) Fenestrated Endovascular Aneurysm Repair (FEVAR), which uses custom-made grafts with openings (fenestrations) to accommodate branch arteries, allowing for treatment of complex aneurysms. 2) Branched Endovascular Aneurysm Repair (BEVAR), which involves the use of branched stent-grafts to maintain blood flow to vital organs while repairing the aneurysm. 3) Polymer-based sealing technology, such as the Nellix EndoVascular Aneurysm Sealing (EVAS) system, which uses a polymer-filled endobag to seal the aneurysm sac and stabilize the endograft. These alternatives are designed to address anatomical challenges and improve patient outcomes.

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Endovascular Repair

EVAR vs ESAR for Abdominal Aortic Aneurysm (HERCULES Trial)

Q: What is the mechanism of action of this treatment?

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.

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

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 below

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I am 18 years old or older.

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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:

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My kidney function is low, with an eGFR below 30.

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I am not a candidate for standard EVAR treatment.

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I have a ruptured or infected aneurysm.

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I have a bleeding disorder that is not under control.

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I have had a stroke or heart attack in the last 3 months.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year follow-up for reporting.

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 more

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

0 / 8Eligibility criteria met

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

613 Previous Clinical Trials

759,433 Total Patients Enrolled

Rijnstate HospitalLead Sponsor

186 Previous Clinical Trials

38,813 Total Patients Enrolled

MMPJ Reijnen, ProfPrincipal InvestigatorRijnstate, Arnhem, the Netherlands

1 Previous Clinical Trials

1,000 Total Patients Enrolled

~200 spots leftby Jun 2027

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