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

Aortic Aneurysm, Abdominal Clinical Trial

— HERCULES  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05484115
• Other study ID #: 2021-1968
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: December 2031

Study information

• Verified date: May 2024
• Source: Rijnstate Hospital
• Contact: Suzanne Holewijn, PhD
• Phone: 0031880057282
• Email: vascularsurgery[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

HERCULES is an investigator driven trial and a collaborative research project with Medtronic. Design; Prospective, post-market, global, multicenter, randomized (1:1), two-arm, superiority trial Up to 300 subjects will be recruited in up to 40 sites in Europe and the US. All subjects shall be followed per local societal guidelines and per the Endurant II/IIs and Heli-FX EndoAnchor instruction for use (IFU) recommendations for post-implant follow-up and CT-imaging, with expected assessments at baseline, index procedure(s), 1-month, and annually at 1, 2, 3, 4, and 5 years post-index procedure. Devices used in HERCULES include the Endurant II/IIs stent graft system (EVAR arm) and the Endurant II/IIs stent graft system plus the Heli-FX EndoAnchor System (ESAR arm) This study is being conducted to collect clinical evidence from treatment of patients with infrarenal AAA having wide proximal aortic neck diameters (≥ 28mm and ≤ 32mm), comparing clinical outcomes with treatment of the AAA with the Endurant II/IIs stent graft in conjunction with Heli-FX EndoAnchors to treatment of the AAA with the Endurant II/IIs stent graft alone. Though both the Endurant II/IIs stent graft and Heli-FX EndoAnchors are commercially approved in this indication, clinical evidence comparing these two treatments in patients with wide proximal aortic neck diameters is not currently available. Collecting clinical data specific to this patient population, including procedure and imaging data as well as long term outcomes, will provide a foundation to further characterize the clinical outcomes of treatment for patients with infrarenal AAA with wide proximal aortic neck diameters.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system
• endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system

Locations

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
United States	Sisters of Charity hospital	Buffalo	New York
United States	University of Missouri	Columbia	Missouri
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	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Promedica Toledo Hospital	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	Medtronic

Countries where clinical trial is conducted

United States,  France,  Netherlands, 

Outcome

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