The STAPLE-International Post-Market Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 108
- 试验地点
- 9
- 主要终点
- Technical Success
研究概览
简要总结
The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.
详细描述
The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.
All subjects diagnosed with a qualifying AAA suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment and should be offered informed consent to participate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years old
- •Patient has given written informed consent
- •Patient has a life expectancy > 1 year
- •Patient is willing to comply with follow-up evaluations
- •Patient's AAA meets at least one of the following criteria:
- •≥ 4.5cm in diameter
- •Increased in size by 0.5cm in last 6 months
- •Maximum diameter exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment
- •Saccular aneurysm larger than 3cm in maximal diameter
- •Patient has a proximal aortic neck diameter measured inner wall to inner wall between 19mm and 29mm
- •Patient has a proximal aortic neck length of at least 12mm
- •Patient has a patent iliac or femoral artery that allows endovascular access to the aneurysmal site with 16Fr (5.3mm) or 18Fr (6.0mm) delivery system.
- •Patient has bilateral iliac artery distal fixation site ≥ 10mm in length with an internal diameter between 9mm and 20mm
排除标准
- •Patient is participating in a concurrent clinical study which may confound STAPLE-International Registry results
- •Patient has a symptomatic AAA
- •Patient's AAA has a proximal aortic neck angle that is > 60 degrees between the infrarenal neck and the long axis of the aneurysm
- •Patient has irregularly-shaped plaque that would inhibit sealing stent apposition
- •Patient has aortic mural pathology that is ≥ 2mm in thickness over ≥ 50% of the circumference of the proximal fixation site
- •Patient has an active, or known history of, bleeding diathesis or hypercoagulable condition
- •Patient has a contraindication to any materials to which he or she will be exposed during the EVAR procedure (i.e., Fortevo Endograft or Heli-FX EndoAnchor System materials, contrast agents)
- •Patient has a genetic connective tissue disorder (e.g., Marfan's or Ehlers-Danloe Syndromes)
结局指标
主要结局
Technical Success
时间窗: Within 24 hours of the Index procedure
The first primary endpoint is primary technical success. It consists of the following items: * Successful arterial access * Successful deployment of the Fortevo Endograft with secure proximal and distal fixation * Absence of type I or III endoleaks * Patent Fortevo Endograft without significant twist, kinking, or obstruction
Major Adverse Events (MAE)
时间窗: Within 1-Month of Implantation
The second primary endpoint is associated with the safety profile of the device, and is defined as the percent of patients experiencing one or more of major adverse events (MAE) within one month of implantation. MAE are defined as any one of the following events: * Death * Myocardial Infarction * Stroke (excludes TIA) * Renal failure (excludes renal insufficiency) * Respiratory Failure (excludes COPD or pulmonary complications) * Paralysis (excludes paraparesis)
次要结局
- Clinical Success and Safety of the Fortevo Endograft and Heli-FX EndoAnchor System components(1-Month, 6-Months and 12-Months)