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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year follow-up

Awards & highlights

HERCULES Trial Summary

This trial compares two treatments for abdominal aortic aneurysm, to see which is more effective.

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.Check my eligibility

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.See study design

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.

HERCULES Trial 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.

HERCULES Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite endpoint at on proximal seal outcomes

Secondary outcome measures

Freedom from aneurysm sac growth

Freedom from migration

Freedom from neck dilatation ≥ 3 mm

+1 more

HERCULES 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor

607 Previous Clinical Trials

828,375 Total Patients Enrolled

Rijnstate HospitalLead Sponsor

180 Previous Clinical Trials

38,320 Total Patients Enrolled

MMPJ Reijnen, ProfPrincipal InvestigatorRijnstate, Arnhem, the Netherlands

1 Previous Clinical Trials

1,000 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment number for this research project?

"Affirmative. According to clinicaltrials.gov, the research project began accepting participants on May 26th 2023 and was last modified on November 15th of that same year. 300 people need to be recruited from 3 different locations for this trial."

Answered by AI

Is enrollment still available for this experimental procedure?

"According to the clinicaltrials.gov website, this trial is actively seeking participants. It was first made accessible on May 26th 2023 and underwent its latest revision on November 15th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck

2023. "Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05484115.

All > Abdominal Aortic Aneurysm