Back to results

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

Primary Purpose

Aortic Aneurysm, Abdominal

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system

endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system

Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with Endoanchors

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Freedom from type IA endoleak

Freedom from migration

Migration of the proximal portion of the stent graft ≥5 mm (compared to 1-month imaging)

Freedom from aneurysm sac growth

Aneurysm sac growth ≥5 mm (compared to 1-month imaging).

Freedom from neck dilatation ≥ 3 mm

Neck dilatation ≥ 3 mm (compared to 1-month imaging).

Full Information

NCT ID

NCT05484115

First Posted

July 6, 2022

Last Updated

April 24, 2023

Sponsor

Rijnstate Hospital

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT05484115

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 2023 (Anticipated)

Primary Completion Date

June 2027 (Anticipated)

Study Completion Date

December 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rijnstate Hospital

Collaborators

Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system

Arm Type

Active Comparator

Arm Title

Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with Endoanchors

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system

Intervention Description

treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system

Intervention Type

Device

Intervention Name(s)

endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system

Intervention Description

treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system

Primary Outcome Measure Information:

Title

Composite endpoint at on proximal seal outcomes

Description

Time Frame

1 year follow-up

Secondary Outcome Measure Information:

Title

Freedom from type IA endoleak

Description

Freedom from type IA endoleak

Time Frame

1 year follow-up

Title

Freedom from migration

Description

Migration of the proximal portion of the stent graft ≥5 mm (compared to 1-month imaging)

Time Frame

1 year follow-up

Title

Freedom from aneurysm sac growth

Description

Aneurysm sac growth ≥5 mm (compared to 1-month imaging).

Time Frame

1 year follow-up

Title

Freedom from neck dilatation ≥ 3 mm

Description

Neck dilatation ≥ 3 mm (compared to 1-month imaging).

Time Frame

1 year follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Suzanne Holewijn, PhD

Phone

0031880057282

vascularsurgery@rijnstate.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Daphne van der Veen, MSc

Phone

0031880057282

vascularsurgery@rijnstate.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MMPJ Reijnen, Prof

Organizational Affiliation

Rijnstate, Arnhem, the Netherlands

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

K. Donas, Prof

Organizational Affiliation

Asklepios Clinic Langen, Langen, Germany

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs