jRCTs032220706招募中不适用
Endurant Stent Graft system vs Excluder endoprosthesis: a global, prospective, randomized clinical trial in sac regression (ADVANCE)
未提供0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 主要终点
- Proportion of subjects with sac regression at 1 year based on CT image as analyzed by Core Lab
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Subject is >= 20 years old
- •Subject and the treating physician agree that the subject will return for all required follow-up visits
- •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
- •Subject has an aneurysm diameter of
- •>= 5 cm (if woman)
- •>= 5.5 cm (if man)
- •In Japan,Subject has aneurysm diameter of >= 5cm(woman and man).
- •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.
- •In Japan,patients with abdominal aortic aneurysms for whom surgical treatment is not the first choice are the target.
排除标准
- •Subject is participating in an investigational drug or device study which may bias or interfere with
- •the endpoints and follow-up of this study
- •Subject has an estimated life expectancy of <= 3 years as judged by the investigator
- •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 arteries
- •g) Ruptured
- •h) Symptomatic AAA
- •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.
- •Subject requires emergent aneurysm treatment, for example, trauma or rupture
- •Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan syndrome,
- •Ehlers Danlos, Loeys-Deitz
- •Subject has previously undergone surgical or endovascular treatment in the abdominal aorta or the iliac arteries for aneurysm or occlusive disease
- •Planned use of aorto-uni-iliac (AUI) main body device
- •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.
- •Planned coverage of the internal iliac artery/arteries
- •Subject has an estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2 or subject is on
- •Subject has a systemic infection who may be at increased risk of endovascular graft infection, per investigator's discretion
- •Subject has a psychiatric or other condition that may interfere with the trial, per investigator's discretion
- •Subject is a female of childbearing potential in whom pregnancy cannot be excluded
- •Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment
- •Subject belongs to a vulnerable population per investigator's judgment
- •Subject has an active COVID-19 infection or relevant history of COVID-19
结局指标
主要结局
Proportion of subjects with sac regression at 1 year based on CT image as analyzed by Core Lab
时间窗: 1 year
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.
次要结局
- Aneurysm sac change by diameter(1-year and annually thereafter up to 5 years)
- Aneurysm sac change by volume(1-year and annually thereafter up to 5 years)
- Type II Endoleaks incidence comparison(1-month, 1-year and annually thereafter up to 5 years)
- Type I Endoleaks incidence comparison(1-month, 1-year and annually thereafter up to 5 years)
- Secondary Interventions incidence comparison(1-month, 1-year and annually thereafter up to 5 years)
- All-Cause Mortality incidence comparison(1-month, 1-year and annually thereafter up to 5 years)
研究者
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