NCT01082185已完成1 期
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Modular Abdominal Stent Graft System
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
研究概览
简要总结
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
详细描述
This study is a prospective, non-randomized multi-center clinical evaluation of the safety and performance of the TriVascular Modular Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysms (AAA).
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
- •Patient is > 18 years of age
- •Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
- •Patient has signed an Ethics Committee approved Informed Consent Form
- •Patient is considered by the treating physician to be a candidate for elective open surgical repair of the AAA (i.e., category I, II, or III per American Society of Anesthesiology (ASA) classification; refer to Appendix III: ASA Classification System). ASA category IV patients may be enrolled provided their life expectancy is greater than 1 year.
- •Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:
- •Abdominal aortic aneurysm >5.0 cm in diameter,
- •Aneurysm that has increased in size by 0.5 cm in last 6 months,
- •Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment.
- •Patient has a patent iliac or femoral arteries that allow endovascular access with the TriVascular Ovation Abdominal Stent Graft System.
- •Patient has a suitable non-aneurysmal proximal aortic neck length of ≥ 7 mm inferior to the most distal renal artery ostium.
- •Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 10 mm. The resultant repair should preserve patency in at least one hypogastric artery.
- •Patient has a suitable non-aneurysmal proximal aortic neck luminal diameter between 16 and 30 mm.
- •Patient has a suitable non-aneurysmal distal iliac luminal diameter between 8 and 20 mm.
- •Patient meets the following anatomic criteria: the distance from the most distal renal artery to most superior internal iliac artery measurement is at least 13 cm.
- •Patient has juxtarenal aortic neck angulation ≤ 60º if proximal neck is ≥ 10 mm and ≤ 45 if proximal neck is <10 mm.
- •Patient must be able and willing to comply with all required follow-up exams.
排除标准
- •Patient has a dissecting aneurysm.
- •Patient has an acutely ruptured aneurysm.
- •Patient has an acute vascular injury.
- •Patient has need for emergent surgery.
- •Patient has a known thoracic aortic aneurysm or dissection.
- •Patient has a mycotic aneurysm or has an active systemic infection..
- •Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
- •Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6 months.
- •Patient has a major surgical or interventional procedure planned ≤ 30 days of the AAA repair.
- •Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
- •Patient has history of bleeding disorders or refuses blood transfusions.
- •Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0 mg/dl.
- •Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
- •Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers, fluorinated ethylene-propylene (FEP) or nitinol.
- •Patient has a body habitus that would inhibit X-ray visualization of the aorta
- •Patient has a limited life expectancy of less than 1 year
- •Patient is currently participating in an investigational device or drug clinical trial.
- •Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
结局指标
主要结局
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
时间窗: 30-Days
次要结局
未报告次要终点
研究者
研究点 (1)
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