NL-OMON51685招募中不适用
EndurAnt Stent Graft system vs ExcluDer endoprothesis: a global, prospectiVe, rANdomized Clinical trial in sac rEgression (ADVANCE Study) - ADVANCE study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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
- •d) Inflammatory
- •e) Pseudoaneurysm
- •f) Concomitant or prior dissection involving the abdominal aorta or iliac
- •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
研究者
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