NCT01980901已完成不适用
A Post-Market Approved (PMA) Post-Approval Study to Evaluate the Long-Term Safety and Effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Freedom From Aneurysm-Related Mortality at 5 Years
研究概览
简要总结
The Post-Approval Study (PAS) will evaluate the "real world" data on the Ovation™/Ovation Prime™ Abdominal Stent Graft System along with the long-term data collected from the IDE cohort to monitor the long-term safety and effectiveness of the device.
详细描述
The purpose of the study is to demonstrate the long term safety and effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment.
The clinical objective of the study is to evaluate the long term safety and effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality.
Additionally, this study will evaluate the physician training program for modifications based on IDE and post-approval experience.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 Institutional Review Board (IRB) 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 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 non-aneurysmal aortic segment
- •Patient has patent iliac or femoral arteries that allow endovascular access with the TriVascular Ovation/Ovation Prime 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 suitable non-aneurysmal distal iliac luminal diameters 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 ≤ 45º if proximal neck is <10 mm. Patient must be willing to comply with all required follow-up exams.
- •Patient must be 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 a 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
Freedom From Aneurysm-Related Mortality at 5 Years
时间窗: 5 Years
The primary endpoint of the Ovation™/Ovation Prime™ Abdominal Stent Graft System study will be determined by evaluating freedom from aneurysm-related mortality at five (5) years. This will be compared to a target performance goal.
次要结局
- Composite Safety and Performance Endpoints(1 Month & Annually 1 to 5 Years)
研究者
研究点 (1)
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