Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 379
- 试验地点
- 2
- 主要终点
- Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit.
研究概览
简要总结
A Descending Thoracic Aneurysm is a bulge in the aorta. The aorta is a large blood vessel that carries blood away from your heart to organs in the rest of your body. Your aneurysm is caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow larger and may ultimately rupture (break open) or extend in size to seriously affect other major arteries in the area. In this Research Study a device will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system. Information will be collected on the performance for the device for 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Talent Captivia Inclusion Criteria
- •Patient is at least 18 years of age.
- •Patient is a surgical or non-surgical candidate
- •Patient has a:
- •Fusiform focal TAA AND / OR
- •Focal saccular TAA or penetrating atherosclerotic ulcer.
- •Subject's anatomy must meet all of the following anatomical criteria:
- •iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories
- •non-aneurysmal aortic diameter in the range of 18-42mm; and
- •non-aneurysmal aortic proximal and distal neck lengths =/>20mm
- •Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CTA) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram (MRA) obtained within the previous three (3) months prior to the implant procedure.
- •Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
- •Patient must be able and willing to undergo follow-up imaging and examinations postoperatively up to 6 months.
- •Talent Captivia
排除标准
- •Planned placement of the COVERED (top edge of fabric) portion of the stent graft requires implant to occur in zones 0 or 1
- •Pregnant female
- •Patient has a connective tissue disease (e.g Marfan's syndrome, medial degeneration).
- •Patient has a mycotic aneurysm or is suspected of having systemic infection.
- •Patient has a history of bleeding diathesis, coagulopathy, or refuses blood transfusions.
- •Patient is currently participating in an investigational drug or device clinical trial that would interfere with the Talent Captivia protocol endpoints or follow-up.
- •The patient has known allergy or intolerance to the device components.
- •The patient has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
- •The patient has another medical condition, which may cause them to be non-compliant with the protocol, confound the data interpretation, or limited life expectancy of less than 6 months.
结局指标
主要结局
Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit.
时间窗: 12 months
Primary Safety Endpoint: rate of "all cause" mortality of TAA repair with the Talent Thoracic Stent Graft against the literature control for open surgical repair within 1 year of follow-up.
时间窗: 12 months
次要结局
未报告次要终点