Clinical trial NCT05484115: Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Keywords: AAA
Endovascular treatment
Wide proximal neck
EndoAnchors
Infrarenal
EVAR (Endovascular aneurysm repair)
ESAR (Endosuture aneurysm repair)
Endurant II/IIs stent graft system
Heli-FX EndoAnchor system
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2022-08-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HERCULES is a post-market, prospective, global, multicenter, randomized (1:1), two-arm, superiority trial designed to compare ESAR to standard EVAR clinical outcomes in treatment of infrarenal AAA in patients having wide proximal aortic neck diameters (≥ 28mm and ≤ 32mm).
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite endpoint at on proximal seal outcomes
timeFrame: 1 year follow-up
Secondary outcomes:
measure: Freedom from type IA endoleak
timeFrame: 1 year follow-up
measure: Freedom from migration
timeFrame: 1 year follow-up
measure: Freedom from aneurysm sac growth
timeFrame: 1 year follow-up
measure: Freedom from neck dilatation ≥ 3 mm
timeFrame: 1 year follow-up
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Regional Medical Center
state: Arkansas
city: Miami Beach
country: United States
facility: Mt Sinai Med Ctr
state: Florida
city: Maywood
country: United States
facility: Loyola
state: Illinois
city: Royal Oak
country: United States
facility: Beaumont University Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Alina Health
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Sisters of Charity hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Raleigh
country: United States
facility: NC Heart& Vascular
state: North Carolina
city: Toledo
country: United States
facility: Promedica Toledo Hospital
state: Ohio
city: Kingsport
country: United States
facility: Ballad Health/Holston Valley
state: Tennessee
city: Richmond
country: United States
facility: Virginia Commonwealth University (VCU)
state: Virginia
city: Lyon
country: France
facility: HCL Lyon
city: Marseille
country: France
facility: Saint Joseph Marseille
city: Nîmes
country: France
facility: Les Franciscaines
city: Bologna
country: Italy
facility: Osp. S.Orsola Malpighi - Bologna
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Ramon Y Cajal
city: Morges
country: Switzerland
facility: EHC-Hôpital de Morges
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital, Glasgow
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: St. George's Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
affiliation: Rijnstate, Arnhem, the Netherlands
name: MMPJ Reijnen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Asklepios Clinic Langen, Langen, Germany
name: K. Donas, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: