ADVANCE study

JRCT ID: jRCTs032220706

Registered date:15/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Abdominal Aortic Aneurysms
• Date of first enrollment: 15/03/2023
• Target sample size: 550
• Countries of recruitment: US,Japan,EU,Japan,Taiwan,Japan
• Study type: Interventional
• Intervention(s): Randamization

Outcome(s)

Primary Outcome

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 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 procedure.

Secondary Outcome

- Aneurysm sac change by diameter at 1-year and annually thereafter up to 5 years as compared to the first CT imaging within 90 days 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 within 90 days 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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
>= 5 cm (if woman)
>= 5.5 cm (if man)
5) Subject's AAA anatomy is appropriate for both 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.

Exclude 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 study
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. Irregular calcium and / or plaque may compromise the fixation and sealing of the implantation sites.
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-Deitz
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) during index 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 a female 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

Related Information

• Primary Sponsor: Shimizu Hideyuki
• Secondary Sponsor: Sato Takuya,MEDTRONIC JAPAN CO., LTD.