EndurAnt Stent Graft system vs ExcluDer endoprothesis: a global, prospectiVe, rANdomized Clinical trial in sac rEgression (ADVANCE Study)
- Conditions
- repair of abdominal aortic aneurysm10002363
- Registration Number
- NL-OMON51685
- Lead Sponsor
- Medtronic B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this trial is to evaluate sac regression outcomes of<br /><br>the Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder<br /><br>Conformable AAA Endoprosthesis in standard EVAR subjects.<br /><br><br /><br>The primary endpoint is defined as the proportion of subjects with sac<br /><br>regression at 1 year based on CT image as analyzed by Core Lab. Sac regression<br /><br>is defined in accordance with Society for Vascular Surgery (SVS) Guidelines as<br /><br>the reduction in maximum diameter of the aneurysm sac by >=5 mm when compared to<br /><br>the first CT imaging study obtained after index procedure.</p><br>
- Secondary Outcome Measures
Name Time Method