NCT02224794已完成不适用
LIFE Study: Least Invasive Fast-Track EVAR With the Ovation® Abdominal Stent Graft Platform
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Major Adverse Events
研究概览
简要总结
The primary objectives of the LIFE Study are to demonstrate the clinical and cost benefits associated with using the Ovation® Abdominal Stent Graft Platform under the least invasive conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR protocol include: appropriate patient selection, bilateral percutaneous access, no general anesthesia, no ICU admission post procedure, and next day discharge.
详细描述
The LIFE Study is a prospective, consecutively enrolling, non-randomized multi center post-market registry to evaluate the ultra low profile (14F) Ovation Abdominal Stent Graft Platform when using in the Percutaneous Endovascular Aneurysm Repair (P-EVAR) treatment of patients with AAA using a Fast-Track EVAR protocol.
250 study patients will be enrolled at up to 40 institutions. Follow-up period is one month.
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 IRB approved informed consent form.
- •Patient is considered by the treating physician to be a candidate for elective open surgical repair of the AAA.
- •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, or maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment.
- •Patient has suitable anatomy that allows use of the TriVascular Ovation® Abdominal Stent Graft Platform.
- •Patient has suitable femoral arteries at the percutaneous access site that allow use of the Perclose ProGlide Suture-Mediated Closure System via the pre-close technique.
- •Patient must be willing to comply with all required follow-up exams.
排除标准
- •Patient has a need for emergent surgery.
- •Patient has a dissecting aneurysm.
- •Patient has an acutely ruptured aneurysm.
- •Patient has an acute vascular injury.
- •Patient has had a previous repair of the abdominal aortic aneurysm or the iliac artery.
- •Patient has a mycotic aneurysm or has an active systemic infection.
- •Patient has unstable angina.
- •Patient has unstable peripheral artery disease with critical limb ischemia.
- •Patient has congestive heart failure.
- •Patient has had a myocardial infarction and/or stroke within the past 3 months.
- •Patient requires use of techniques that would cover the renal arteries.
- •Patient requires planned adjunctive devices to complete the procedure.
- •Patient has a major surgical or interventional procedure planned during or within ±30 days of the AAA repair.
- •Patient has history of connective tissue disease.
- •Patient has history of bleeding disorders or refuses blood transfusions.
- •Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0mg/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 is on home oxygen.
- •Patient is morbidly obese (BMI ≥40 kg/m2).
- •Patient was admitted from a skilled nursing facility.
- •Patient has a limited life expectancy of less than 1 year.
- •Patient has an inability to be discharged within 1 day of the procedure.
- •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
Major Adverse Events
时间窗: 30 days
次要结局
- Assess technical success, defined as percent of procedures successfully completed with bilateral percutaneous access(30 days)
- Fluoroscopy time(30 days)
- Percent of procedures completed without general anesthesia(30 days)
- Contrast volume(30 days)
- Serious and non-serious adverse events, including vascular and major access site vascular complications(30 days)
- Treatment success, defined as percent of subjects who successfully follow least invasive protocol through discharge(30 days)
- Anesthesia time(30 days)
- Procedure time(30 days)
- Time to normal diet(30 days)
- Percent of subjects discharged without ICU admission(30 days)
- Length of ICU stay, if required(30 days)
- Length of hospital stay(30 days)
- Freedom from AAA rupture(30 days)
- Blood loss, including if transfusion required(30 days)
- Time to ambulation(30 days)
- Groin pain(30 days)
- Quality of Life(30 days)
- Freedom from conversion to open repair(30 days)
- Freedom from mortality(30 days)
- Time to hemostasis(30 days)
- Percent of subjects discharged within only one midnight stay(30 days)
- Freedom from type I and III endoleaks(30 days)
- Freedom from AAA related secondary interventions(30 days)
研究者
研究点 (2)
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