NCT00507559已完成不适用
The Pivotal Study of the Aptus Endovascular AAA Repair System
Medtronic Cardiovascular4 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 4
- 主要终点
- Effectiveness: Composite Success Rate
研究概览
简要总结
A prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair historical control group in the treatment of abdominal aortic aneurysms (AAA).
详细描述
The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infrarenal AAA with a maximum diameter ≥ 4.5 cm.
- •Infrarenal AAA with at least 12 mm length of non-aneurysmal proximal neck.
- •Infrarenal AAA with a proximal neck internal diameter between 19-29 mm.
- •Infrarenal AAA with an internal diameter at the aortic bifurcation ≥ 18 mm.
- •Infrarenal AAA with an angle of ≤ 60° relative to the long axis of the aneurysm.
- •Bilateral iliac artery distal fixation sites ≥ 10 mm in length.
- •Bilateral iliac arteries with an internal diameter between 9 and 20 mm.
- •Bilateral femoral/iliac arteries with morphology compatible with standard vascular access techniques and vessel size must accommodate a 16F (5.3 mm) or 18F (6.0 mm) delivery system.
排除标准
- •Myocardial infarction within past 10 weeks.
- •Active systemic infection.
- •Ruptured or leaking AAA.
- •Mycotic or inflammatory AAA.
- •Genetic connective tissue disorders (e.g., Marfans or Ehlers-Danlos Syndromes).
- •Concomitant TAA or thoracoabdominal aortic aneurysms.
- •Requires emergent AAA surgery.
- •Previous AAA repair.
- •Patients with a body habitus that would prevent imaging required by the study.
- •Patient has significant comorbid conditions that pose undue risk of general anesthesia or endovascular surgery.
- •Patient requires additional planned major procedure at the time of AAA repair or within 30 days before or after AAA repair.
- •Dialysis dependent renal failure or creatinine > 2.5 mg/dL.
- •Allergy to or intolerance of radiopaque contrast agents.
- •Patients with a known sensitivity or allergy to implant materials.
- •Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure.
- •Patients with history of bleeding diathesis or hypercoagulable condition.
- •Patients with thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180°) continuous coverage of the vessel circumference in the intended seal zone.
- •Patients with irregular shaped calcification and/or plaque that may compromise the fixation and sealing at the proximal or distal implantation sites.
结局指标
主要结局
Effectiveness: Composite Success Rate
时间窗: 12 months
Composite endpoint of delivery success, absence of Type I/III endoleak requiring intervention post-index procedure, absence of migration (\>10mm), and absence of aneurysm rupture or conversion.This composite endpoint is compared to an estimated success rate of 80%.
Safety: MAE (Major Adverse Event)
时间窗: 30 days
Percentage (number) of subjects experiencing one or more of major adverse events within the first 30 days post-index procedure compared to the open surgical repair historical group
次要结局
- Effectiveness: EndoStaple Stent/Fracture(12 months)
- Effectiveness: Prosthesis Migration(12 months)
- Effectiveness: Aneurysm Change(12 months)
- Effectiveness: Aneurysm Rupture(12 months)
- Effectiveness: Type I Endoleak and Type III Endoleak(12 months)
- Safety: SAE (Serious Adverse Event)(5 years)
- Effectiveness: Surgical Conversion(12 months)
- Effectiveness: Thrombosis(5 years)
研究者
研究点 (4)
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