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New treatment option for Aortic Aneurysm, Abdominal
Official title Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
ClinicalTrials.gov ID: NCT05484115
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older
- Provided written informed consent
- Clinical necessity for treatment of the AAA, according to the current guidelines in the geographies participating
- Elective repair
- Eligible anatomy for treatment with the Endurant II/IIs stent graft system and Heli-FX EndoAnchor system according to the IFU of both devices
You likely can't join if
- Anatomy outside the IFU of the ndurant II/IIs stent graft system and Heli-FX EndoAnchor system
- Planned use of AUI main body device
- Patient is participating in another clinical study, potentially conflicting with the outcomes of the current study.
- Patient with eGFR \< 30 ml/min/1.73m2 before the intervention
- Patient's life expectancy \<2 years as judged by the investigator
- Patient has a psychiatric or other condition that may interfere with the study
See the full eligibility criteria
- Age 18 years or older
- Provided written informed consent
- Clinical necessity for treatment of the AAA, according to the current guidelines in the geographies participating
- Elective repair
- Eligible anatomy for treatment with the Endurant II/IIs stent graft system and Heli-FX EndoAnchor system according to the IFU of both devices
- Infrarenal neck diameter ≥ 28 mm and ≤32 mm
- Proximal neck length ≥10mm
- Anatomy outside the IFU of the ndurant II/IIs stent graft system and Heli-FX EndoAnchor system
- Planned use of AUI main body device
- Patient is participating in another clinical study, potentially conflicting with the outcomes of the current study.
- Patient with eGFR \< 30 ml/min/1.73m2 before the intervention
- Patient's life expectancy \<2 years as judged by the investigator
- Patient has a psychiatric or other condition that may interfere with the study
- Patient has a known allergy to any device component
- Patients with a systemic infection who may be at increased risk of endovascular graft infection.
- Patient has a coagulopathy or uncontrolled bleeding disorder
- Patient has a ruptured, leaking, or mycotic aneurysm
- Patient is not eligible for standard EVAR
- Patient had a Cerebro Vascular Accident (CVA) or a myocardial infarction (MI) within the prior three months
- Patient is pregnant (Female patients of childbearing potential only)
- Patient has active COVID-19 infection or has been diagnosed with long COVID-19 requiring hospitalization within the 6 months prior to procedure.
- Patient has previously been treated with stent grafts in the aorto-iliac arteries
The study team makes the final eligibility decision.
Where it's taking place
- Washington, Arkansas, United States
- Miami Beach, Florida, United States
- Maywood, Illinois, United States
- Detroit, Michigan, United States
- Royal Oak, Michigan, United States
- Minneapolis, Minnesota, United States
- Columbia, Missouri, United States
- St Louis, Missouri, United States
- New Brunswick, New Jersey, United States
- Buffalo, New York, United States
- Stony Brook, New York, United States
- Raleigh, North Carolina, United States
- Toledo, Ohio, United States
- Hershey, Pennsylvania, United States
- Kingsport, Tennessee, United States
- Richmond, Virginia, United States
- Lyon, France
- Marseille, France
- Nîmes, France
- Langen, Hesse, Germany
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington, Arkansas, United States; Miami Beach, Florida, United States; Maywood, Illinois, United States; Detroit, Michigan, United States; Royal Oak, Michigan, United States; Minneapolis, Minnesota, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.