Early Feasibility Assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms Involving the Visceral Branch Vessels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 11
- 主要终点
- Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
研究概览
简要总结
This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.
详细描述
This is a prospective, non-randomized study designed to assess the feasibility of the TAMBE Device in the treatment of patients with aortic aneurysms involving the visceral branch vessels. A maximum of 10 Subjects will be treated under this Protocol. This clinical study will include up to six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, contrast-enhanced computed tomography (CT) of chest, abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis implant.
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
- •Aortic aneurysm involving the visceral vessels requiring treatment
- •Adequate access for TAMBE Device components
- •Appropriate aortic anatomy to receive the TAMBE Device
- •Age ≥ 18 years at the time of informed consent signature
- •Male or infertile female
- •The patient is considered high risk for open repair as deemed by the treating physician
- •Capable of complying with protocol requirements, including follow-up
- •An Informed Consent Form signed by Subject or legal representative Note: Additional Inclusion Criteria may apply
排除标准
- •Prior aortic surgery
- •Ruptured or leaking aortic aneurysm
- •Aneurysmal dilatation due to chronic aortic dissection
- •Infected aorta
- •Mycotic aneurysm
- •Life expectancy <2 years
- •Myocardial infarction or stroke within 6 weeks of treatment
- •Systemic infection which may increase risk of endovascular graft infection
- •Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
- •Participation in another drug or medical device study within 1 year of study enrollment
- •History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment
- •Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access
- •Known sensitivities or allergies to the device materials
- •Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
- •Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
- •Renal Insufficiency Note: Additional Exclusion Criteria may apply
结局指标
主要结局
Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
时间窗: Absence of procedural safety events through 30 days post procedure
Absence of the following procedural safety events through 30 days post-procedure: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
次要结局
- Patency (Primary, Assisted Primary, and Secondary)(12-month)
- Absence of Type I and Type III Endoleaks at One Month Follow-up(One Month followup)
- Technical Success, Including Individual Components of Technical Success(12-month)
- Device Integrity, Including Individual Components of Device Integrity(12-month)