Aortic Aneurysm, Abdominal Clinical Trial
— HERCULESOfficial title:
Randomized Controlled Clinical Trial on the Application of Heli-FX EndoAnchors in Conjunction With the Endurant II/IIs Endograft in Infrarenal Aortic Aneurysms With a Wide Infrarenal Neck (HERCULES Trial)
NCT number | NCT05484115 |
Other study ID # | 2021-1968 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 26, 2023 |
Est. completion date | December 2031 |
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).
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2031 |
Est. primary completion date | June 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | HCL Lyon | Lyon | |
France | Saint Joseph Marseille | Marseille | |
France | Les Franciscaines | Nîmes | |
Netherlands | Rijnstate hospital | Arnhem | |
Netherlands | Catharina Ziekenhuis | Eindhoven | |
Spain | Hospital Clinic de Barcelona | Barcelona | |
Switzerland | EHC-Hôpital de Morges | Morges | |
United Kingdom | Queen Elizabeth University Hospital, Glasgow | Glasgow | |
United Kingdom | St. Mary's Hospital | London | |
United States | Sisters of Charity hospital | Buffalo | New York |
United States | University of Missouri | Columbia | Missouri |
United States | Ballad Health/Holston Valley | Kingsport | Tennessee |
United States | Mt Sinai Med Ctr | Miami Beach | Florida |
United States | Alina Health | Minneapolis | Minnesota |
United States | Robert Wood Johnson University Medical Center | New Brunswick | New Jersey |
United States | NC Heart& Vascular | Raleigh | North Carolina |
United States | Virginia Commonwealth University (VCU) | Richmond | Virginia |
United States | Beaumont University Hospital | Royal Oak | Michigan |
United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
United States | Stony Brook University Medical Center | Stony Brook | New York |
United States | Promedica Toledo Hospital | Toledo | Ohio |
United States | Washington Regional Medical Center | Washington | Arkansas |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital | Medtronic |
United States, France, Netherlands, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite endpoint at on proximal seal outcomes | The primary endpoint is a composite endpoint based on core lab reported data from computed tomography (CT) with contrast imaging of freedom from:
type IA endoleak and Migration of the proximal portion of the stent graft =5 mm (compared to 1-month imaging) and Aneurysm sac growth =5 mm (compared to 1-month imaging). |
1 year follow-up | |
Secondary | Freedom from type IA endoleak | Freedom from type IA endoleak | 1 year follow-up | |
Secondary | Freedom from migration | Migration of the proximal portion of the stent graft =5 mm (compared to 1-month imaging) | 1 year follow-up | |
Secondary | Freedom from aneurysm sac growth | Aneurysm sac growth =5 mm (compared to 1-month imaging). | 1 year follow-up | |
Secondary | Freedom from neck dilatation = 3 mm | Neck dilatation = 3 mm (compared to 1-month imaging). | 1 year follow-up |
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