The purpose of this study is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft System versus Gore Excluder/Excluder Conformable AAA Endoprosthesis in subjects with AAA.
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this trial is to evaluate sac regression outcomes of
the Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder
Conformable AAA Endoprosthesis in standard EVAR subjects.
The primary endpoint is defined as the proportion of subjects with sac
regression at 1 year based on CT image as analyzed by Core Lab. Sac regression
is defined in accordance with Society for Vascular Surgery (SVS) Guidelines as
the reduction in maximum diameter of the aneurysm sac by >=5 mm when compared to
the first CT imaging study obtained after index procedure.
Secondary outcome
A secondary objective of this trial is to investigate predictors of sac
regression as well as stability and expansion. The trial evaluates whether sac
dynamics predict late mortality and reinterventions. Analysis is also performed
to evaluate the difference in sac diameter and volume between treatment groups.
To evaluate rates of pre-specified parameters allowing investigation of
secondary objectives, the following endpoints are evaluated:
• Aneurysm sac change by diameter at 1-year and annually thereafter up to 5
years as compared to the first CT imaging after index procedure
• Aneurysm sac change by volume at 1-year and annually thereafter up to 5 years
as compared to the first CT imaging after index procedure
• Type II Endoleaks incidence comparison between treatment groups through
1-month, 1-year and annually thereafter up to 5 years
• Type I Endoleaks incidence comparison between treatment groups through
1-month, 1-year and annually thereafter up to 5 years
• Secondary Interventions incidence comparison between groups through 1-month,
1-year and annually thereafter up to 5 years
• All-Cause Mortality incidence comparison between groups through 1-month,
1-year and annually thereafter up to 5 years
Background summary
Pls see CIP section 4.1 page 18 to 22
Study objective
The purpose of this study is to generate clinical evidence related to key
performance outcomes of Endurant II/IIs Stent Graft System versus Gore
Excluder/Excluder Conformable AAA Endoprosthesis in subjects with AAA.
Study design
This study is designed as a post-market, prospective, interventional,
nonblinded, global, multi-center, randomized (1:1), dual arm, study. The study
is being conducted to collect clinical evidence of treatment of abdominal
aortic aneurysm with Endurant II/IIs Stent Graft System compared to Gore
Excluder/Excluder Conformable Endoprosthesis in subjects with AAA indicated for
an EVAR procedure. CT imaging will be performed at every follow-up visit, which
follows the long-term surveillance recommendations of the Instruction for Use
(IFU). The study is expected to be conducted at up to 100 study sites located
in Europe, the United States, Japan and Taiwan. A estimate of 550 subjects will
be enrolled in the study ( minimum 500) with a potential to increase the sample
size (upper limit of 900 subjects) based on predictive probability analysis to
achieve superiority for the primary endpoint at pre-specified interim analyses
for sample size evaluations. The expected duration of each subject*s
participation is up to 5 years after the index procedure.
In accordance with EU MDR, the preceding investigation procedure in this study
is defined as CT imaging with contrast during follow up visits up to 5 years.
Intervention
Subjects who meet the eligibility criteria and enroll will be followed for five
years. Clinical data should be collected at baseline, index procedure, hospital
discharge, 1-month, 1 year and annually through 5 years.
Additional imaging studies may be recommended at physician*s discretion in
cases of specific events including but not limited to the presence of an
endoleak or aneurysm sac enlargement. The sponsor will require submission of
all follow-up imaging as well as any relevant additional imaging studies for
analysis by the sponsor and/or independent Core Laboratory.
See for more information CIP section 10.1 Schedule of Events
Study burden and risks
EVAR is now established as having an acceptable safety profile and is
considered an effective treatment option for subjects with symptomatic
abdominal aortic aneurysms who are at low to extreme risk for open surgical
repair of AAA.
Appropriate risk management activities have been performed for the Endurant
II/IIs Stent Graft system and/or Gore Excluder/Excluder Conformable system
resulting in a positive risk-to-benefit rationale given the products have
received local regulatory body approval.
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
Inclusion criteria
Inclusion Criteria:
Subjects must meet ALL of the following inclusion criteria:
1) Subject is >= 20 years old
2) Subject and the treating physician agree that the subject will return for all
required follow-up visits
3) Subject or legal representative or consultee, as applicable, has consented
for study participation and signed the Informed Consent approved by the sponsor
and by the Ethics Committee/Institutional Review Board
4) Subject has an aneurysm diameter of
o >= 5 cm (if woman)
o >= 5.5 cm (if man)
5) Subject's AAA anatomy is appropriate for both Medtronic Endurant II/IIs
Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis as
per assessment of both treating physician and Core Lab in accordance with the
overlapping commercially available IFUs per applicable region.
Exclusion criteria
Subjects are NOT eligible for trial participation if they meet ANY of the
following exclusion criteria:
1. Subject is participating in an investigational drug or device study which
may bias or interfere with the endpoints and follow-up of this trial
2. Subject has an estimated life expectancy of <= 3 years as judged by the
investigator
3. Subject has an aneurysm that is:
a) Suprarenal/pararenal/juxtarenal
b) Isolated ilio-femoral
c) Mycotic
d) Inflammatory
e) Pseudoaneurysm
f) Concomitant or prior dissection involving the abdominal aorta or iliac
arteries
g) Ruptured
h) Symptomatic AAA
4. Subject has significant thrombus and / or calcium at the arterial
implantation sites, specifically the proximal aortic neck and distal iliac
artery interface. Significant thrombus may be quantified as thrombus >= 2 mm in
thickness and / or >= 25% of the vessel circumference in the intended seal zone
of the aortic neck.
5. Subject requires emergent aneurysm treatment, for example, trauma or rupture
6. Subject with connective tissue disease that may have caused the aneurysm
e.g., Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome
7. Subject has previously undergone surgical or endovascular treatment in the
abdominal aorta or the iliac arteries for aneurysm or occlusive disease
8. Planned use of aorto-uni-iliac (AUI) main body device
9. Any planned additional device (apart from the main body, limb stent graft
and extensions per assigned treatment per randomization) duringindex or staged
procedure, (e.g., endostaple or anchor, Iliac branch endoprosthesis,
embolization ,etc. )
10. Planned coverage of the internal iliac artery/arteries
11. Subject has an estimated glomerular filtration rate (eGFR) < 45
ml/min/1.73m² or subject is on dialysis
12. Subject has a systemic infection who may be at increased risk of
endovascular graft infection, per investigator*s discretion
13. Subject has a psychiatric or other condition that may interfere with the
trial, per investigator*s discretion
14. Subject is of childbearing potential in whom pregnancy cannot be excluded
15. Subject has a known hypersensitivity or contraindication to anticoagulants,
anti-platelets, or contrast media, which is not amenable to pre-treatment
16. Subject belongs to a vulnerable population per investigator's judgment
17. Subject has an active COVID-19 infection or relevant history of COVID-19
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 | NCT05378347 |
| CCMO | NL81693.078.22 |