A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 61
- 主要终点
- Rate of Major Adverse Events (MAEs)
研究概览
简要总结
Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.
详细描述
The objective of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject must be ≥ 18 years of age
- •Subject has specified disease in his/her descending thoracic aorta.
- •Subject have anatomical compliance for the device specified for both access vessels and treatment area.
- •Subject must be willing to comply with the follow-up evaluation schedule.
- •Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment.
排除标准
- •Subject has specified disease of the thoracic aorta which is not included in the trial, for example: aortic dissection, intramural hematoma, traumatic injury or transection, aortic false aneurysm, ruptured aneurysm.
- •Subject anatomy with significant stenosis, calcification, thrombus or tortuosity.
- •Subjects with specified compromised circulation.
- •Subjects with specified prior procedures.
- •Subjects with allergy to contrast media or device components.
- •Subjects with disease, for example: suspected connective tissue disorder, specified coagulation disorders, specified coronary artery disease, severe congestive heart failure, stroke and/or Myocardial Infarction (MI) as specified, specified pulmonary disease, specified renal failure.
- •Subjects that are pregnant or planning to become pregnant during the course of the study.
结局指标
主要结局
Rate of Major Adverse Events (MAEs)
时间窗: 30 days
Primary safety endpoint is a composite of the following MAEs occurring through 30 days: * Death * Stroke (excluding transient ischemic attack) * Paralysis (excludes paraparesis)
Absence of aneurysm expansion (> 5 mm diameter increase)
时间窗: 12 months
Primary effectiveness as measured by the absence of aneurysm expansion (\> 5 mm diameter increase) through 12 months, compared to the first post-procedural computed tomographic (CT) imaging study.
Absence of stent-graft migration
时间窗: 12 months
Primary effectiveness as measured by the absence of stent-graft migration (\> 10 mm) through 12 months, compared to the first post-procedural CT.
Aneurysm rupture
时间窗: 12 months
Primary effectiveness as measured by the absence of aneurysm rupture through 12 months.
Absence of Type I and III endoleak through 12 months;
时间窗: 12 months
Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months.
Technical success
时间窗: 24 hours
Primary effectiveness rate as measured by the technical success through 24 hours, defined as: * Successful delivery of the device through the vasculature; * Successful deployment of the device at the intended location; Absence of Type I or III endoleaks; Patent stent-graft without significant stenosis.
Stent graft patency
时间窗: 12 months
Primary effectiveness as measured by the rate of stent-graft patency through 12 months.
Absence of stent fractures in the attachment zone through 12 months
时间窗: 12 months
Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 12 months.
Absence of open or endovascular secondary interventions
时间窗: 12 months
Primary effectiveness as measured by the absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months.
次要结局
- Rate of aneurysm expansion(1 month and 6 months)
- Individual outcomes of composite MAEs(6 months and 12 months)
- Time in Intensive Care Unit (ICU)(Treatment Visit through Discharge Visit)
- Rate of stent fractures in the attachment zone(1 month and 6 months)
- Incidence of open or endovascular secondary interventions(1 month and 6 months)
- Rate of stent-graft migration(1 month and 6 months)
- Loss of stent-graft patency(1 month and 6 months)
- Rate of aneurysm rupture(1 month and 6 months)
- Rate of endoleaks of all types(1 month, 6 months and 12 months)
- Rate of vascular access complications(During the initial implant attempt)
- Duration of implant procedure(Treatment Visit)
- Number of blood transfusions(Treatment Visit through Discharge Visit)
- Duration of hospitalization(Treatment Visit through Discharge Visit)