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)

Overview

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.

Interventions

• 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
• Device 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

Primary outcome measures

• Composite endpoint at on proximal seal outcomes [Time frame: 1 year follow-up]

Secondary outcome measures (4)

• Freedom from type IA endoleak [Time frame: 1 year follow-up]
• Freedom from migration [Time frame: 1 year follow-up]
• Freedom from aneurysm sac growth [Time frame: 1 year follow-up]
• Freedom from neck dilatation ≥ 3 mm [Time frame: 1 year follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 16 centers

• Washington Regional Medical Center — Washington
• Mt Sinai Med Ctr — Miami Beach
• Loyola — Maywood
• Henry Ford Hospital — Detroit
• Beaumont University Hospital — Royal Oak
• Alina Health — Minneapolis
• University of Missouri — Columbia
• Barnes-Jewish Hospital — St Louis
• … and 8 more centers

Netherlands · 4 centers

• Noordwest ziekenhuis — Alkmaar
• Spaarne Gasthuis — Haarlem
• Rijnstate hospital — Arnhem
• Catharina Ziekenhuis — Eindhoven

United Kingdom · 4 centers

• Queen Elizabeth University Hospital, Glasgow — Glasgow
• Leeds General Infirmary — Leeds
• St. George's Hospital — London
• St. Mary's Hospital — London

France · 3 centers

• HCL Lyon — Lyon
• Saint Joseph Marseille — Marseille
• Les Franciscaines — Nîmes

Germany · 3 centers

• Asklepios Klinik Langen — Langen
• Universitatsklinikum Frankfurt — Frankfurt
• University Hospital Leipzig — Leipzig

Spain · 3 centers

• Hospital Clinic de Barcelona — Barcelona
• Hospital Clinico Universitario Lozano Blesa — Zaragoza
• Hospital Universitario Miguel Servet — Zaragoza

Italy · 2 centers

• IRCCS Ospedale Policlinico San Martino — Genova
• Osp. S.Orsola Malpighi - Bologna — Bologna

Switzerland · 1 center

• EHC-Hôpital de Morges — Morges

Identifiers

NCT: NCT05484115 · 2021-1968

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗