The primary objective of this study is to investigate if the use of Heli-FX EndoAnchors in conjunction with placement of aortic stent grafts under instructions for use (IFU) conditions in aneurysms with a wide neck is superior to treatment with…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is a composite based on core lab reported data from
computed tomography (CT) with contrast imaging of freedom from:
(1) type IA endoleak AND
(2) Migration of the proximal portion of the stent graft >=5 mm (compared to
1-month imaging) AND
(3) Aneurysm sac growth >=5 mm (compared to 1-month imaging).
Secondary outcome
The following secondary endpoints will be evaluated using core lab reported
data :
• Freedom from type IA endoleak
• Freedom from migration of the proximal portion of the stent graft >= 5 mm
(compared to 1-month imaging)
• Freedom from aneurysm growth >= 5 mm (compared to 1-month imaging)
• Freedom from neck dilatation >=3 mm
Background summary
After more than 25 years of Endovascular Aneurysm Repair (EVAR) researchers are
still unraveling the factors that attribute to a more or less favorable outcome
on the long-termoutcome after EVAR. Wide necks have been identified as one of
the parameters of a hostile neck and are typically defined as a neck with a
diameter of 28 mm or more. It was recently shown that the use standard EVAR
requiring a 34- to 36-mm diameter endograft is independently associated with an
increased rate of proximal fixation failure, which was a composite of type IA
endoleak and stent graft migration >10 mm after EVAR. A recent review revealed
that patients with a wide proximal aortic neck undergoing standard EVAR have a
lower freedom from aneurysm-related reinterventions, type IA endoleak, sac
expansion and aneurysm rupture. The authors concluded that a wide neck should
be taken into consideration when establishing a treatment.
Heli-FX EndoAnchors have successfully been applied to resolve type IA endoleaks
in patients with a hostile neck anatomy, but they have also been used to
prevent endoleaks in patients with an aneurysm with a short infrarenal neck. In
an analysis of the ANCHOR registry it was shown that the Endurant II/IIs
endograft in conjunction with Heli-FX EndoAnchor implants (ESAR) is a safe and
effective treatment option with a high technical success rate and low incidence
of type IA endoleaks and secondary interventions. In addition, the use of
Heli-FX EndoAnchors also appears to have a protective effect on neck
dilatation, which is particularly relevant in patients with a wide neck. They
have recently also been related to aneurysm shrinkage after EVAR, implying a
better seal.
This study is being conducted to collect clinical evidence from treatment of
patients with infrarenal Infrarenal abdominal aortic aneurysm (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.
Study objective
The primary objective of this study is to investigate if the use of Heli-FX
EndoAnchors in conjunction with placement of aortic stent grafts under
instructions for use (IFU) conditions in aneurysms with a wide neck is superior
to treatment with stent grafts alone in regards to proximal seal outcomes.
The secondary objective of this study is to investigate if the use of Heli-FX
EndoAnchors in aneurysms with a wide neck reduces the occurrence of Type IA
endoleak, migration, aneurysm sac growth, and neck dilatation and if Heli-FX
EndoAnchors positively affect aneurysm remodelling in patients with a wide
infrarenal neck.
Study design
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 (>= 28 mm and <= 32 mm).
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.
Study burden and risks
Any surgical procedure poses a potential risk. The procedures undertaken as
part of this study are no exception. There are known risks associated with the
use of anaesthesia and risks associated with a surgical procedure involving a
device. The risks, adverse events and complications associated with the study
devices are clearly identified in the Instructions for Use (IFUs), which are
inlcuded in the submission package.
As such, risks associated with endovascular device implant procedures are
identical to procedures undertaken as part of standard care treatments; all
patients to be included are eligible for either one of the treatment arms, so
no additional risks exist in regards to the procedural implant procedure.
Regular CT-scans with contrast are required at follow-up visits. In certain
cases, these CT-scans are not standard of care and could potentially be an
additional risk to the patients. Howver, as detailed in the document "Radiation
Dose Justiification Hercules trial_16Feb2023" signed J. Simmering (and included
in the submission), the radiation exposure dose falls in risk category IIa
which is an acceptable risk when it *increases in knowledge leading to health
benefit".
.
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
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 endograft and Heli-FX
EndoAnchors 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 Endurant II/IIs endograft and/or Heli-FX
EndoAnchors
• 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05484115 |
| CCMO | NL82691.091.22 |