Valiant Evo US Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 42
- 主要终点
- Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure
研究概览
简要总结
The purpose of the Valiant Evo US Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.
详细描述
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 total subjects, in order to obtain 87 evaluable subjects for the primary endpoint. The two protocols are identical, and the trials were run simultaneously to enroll subjects concurrently in the United States (US) and Outside United States (OUS). The poolability on the primary endpoint between US and OUS data will be assessed using Fisher's exact test during the data analysis. Data for both trials will be combined and presented as a pooled analysis.
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 is ≥18 years old.
- •Subject understands and voluntarily has signed and dated the Informed Consent Form approved by the Sponsor and by the Ethics Committee for this study.
- •Subject presents a Descending Thoracic Aortic Aneurysm (DTAA) which is localized below the ostium of Left Subclavian Artery (LSA) and above the ostium of celiac trunk
- •Subject has a DTAA that is one of the following:
- •A fusiform aneurysm with a maximum diameter that:
- •is ≥ 50 mm and/or:
- •is > 2 times the diameter of the non-aneurysmal thoracic aorta and/or:
- •is < 50 mm and has grown ≥ 5 mm within previous 12 months
- •A saccular aneurysm or a penetrating atherosclerotic ulcer
- •Subject's anatomy must meet all of the following anatomical criteria as demonstrated on contrast-enhanced CT and/or on contrast-enhanced Magnetic Resonance Angiogram (MRA) obtained within four (4) months prior to implant procedure:
- •Proximal and distal non-aneurysmal aortic neck diameter measurements must be ≥ 16 mm and ≤ 42 mm;
- •Proximal non-aneurysmal aortic neck length must be ≥ 20 mm (for FreeFlo configuration) and ≥ 25 mm (for Closed Web configuration) distal to the left common carotid artery (LCCA). Note: Proximal aortic neck length may include covering the LSA (with or without discretionary revascularization) when necessary to optimize device fixation and maximize aortic neck length. If occlusion of the LSA ostium is required to obtain adequate neck length for fixation and sealing, transposition or bypass to the LSA may be warranted.
- •Distal non-aneurysmal aortic neck length must be ≥ 20 mm
- •Subject has adequate arterial access site or can tolerate a conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate sized device chosen for the treatment.
排除标准
- •Subject has a life expectancy of less than 1 year
- •Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study.
- •Subject is pregnant.
- •Subject requires planned placement of the covered proximal end of the stent graft to occur in zones 0 or
- •Subject has a thoracic aneurysm with a contained rupture or localized at the anastomosis of a previous graft (pseudo-/false aneurysm).
- •Subject has a mycotic aneurysm.
- •Subject has a dissection (type A or B) or an intramural hematoma or an aortic rupture in addition to the thoracic aneurysm.
- •Subject requires emergent aneurysm treatment, e.g., trauma or rupture.
- •Subject has received a previous stent or stent graft or previous surgical repair in the ascending and/or descending thoracic aorta, and/or in the aortic arch.
- •Subject requires surgical or endovascular treatment of an infra-renal aneurysm at the time of implant
- •Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm.
- •Treatment with the Valiant Evo Thoracic Stent Graft would require intentional revascularization of the brachio-cephalic artery or the left common carotid artery or the celiac trunk.
- •Subject has had or plans to have a major surgical or interventional procedure within 30 days before or 30 days after the planned implantation of the Valiant Evo Thoracic Stent Graft. This does not include planned procedures that are needed for the safe and effective placement of the stent graft (i.e., carotid/subclavian transposition, carotid/subclavian bypass procedure).
- •Subject has a significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that could compromise fixation and seal of the implanted stent graft.
- •Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration).
- •Subject has a bleeding diathesis or coagulopathy, or refuses blood transfusion.
- •Subject has had a Myocardial Infarction (MI) within 3 months of the procedure.
- •Subject has had a Cerebrovascular Accident (CVA) within 3 months of the procedure.
- •Subject has a known allergy or intolerance to the device materials
- •Subject has a known allergy to anesthetic drugs
- •Subject has a known hypersensitivity or contraindication to anticoagulants, or contrast media, which is not amenable to pretreatment.
- •Subject has active or systemic infection at the time of the index procedure.
结局指标
主要结局
Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure
时间窗: 30 Days
MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture. Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries. Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test.
次要结局
- Safety and Effectiveness Outcome(60 Month)