Multicenter, Post-Market Study to Assess Outcomes of Patients Treated With the AFX System Compared to Other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair: LEOPARD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 455
- 试验地点
- 112
- 主要终点
- Number of Patients With Absence of Aneurysm Related Complications (ARC)
研究概览
简要总结
The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S clinical centers will be involved in the trial to include a broad range of experience. Imaging data will be evaluated by an independent core lab.
详细描述
This trial is a prospective, randomized, multi-center trial, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The trial is designed to compare the anatomically stabilized AFX Endograft System to a reference group of proximally fixated EVAR devices. Patients will be randomized between the two groups.
Randomization will be 1:1. Each investigator will select one comparator device of their choice before enrolling the first patient. The study will sequentially evaluate non-inferiority and superiority hypotheses.
Up to 80 sites with experience in EVAR and up to 800 subjects will participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male or female at least 18 years old
- •Subjects with minimum of 2 year life expectancy
- •Subjects have signed the informed consent document for data release
- •Subjects with infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.
排除标准
- •Currently participating in another study where primary endpoint has not been reached yet
- •Known allergy to any of the device components
- •Pregnant (females of childbearing potential only)
- •Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR
结局指标
主要结局
Number of Patients With Absence of Aneurysm Related Complications (ARC)
时间窗: 1 year
ARC is a composite of the most relevant EVAR outcomes and includes: * Peri-Operative Death (\< 30 days) * Rupture * Conversion to OSR * Endoleaks; post-operative * Migration (≥ 10mm) * Aneurysm Enlargement (≥ 5mm) * Endograft Limb Occlusions * Reinterventions for device- or aneurysm-related complications
次要结局
- The Number of MAEs(At 30 days, 12 months, and annually up to five years)
- The Number of Participants With Aneurysm Related Complications (ARC)(Post 12 Months up to Five Years)
- The Number of Participants With Aneurysm Related Mortality(Up to Five Years)
- Number of Participants With Open Conversion(12 Months, 24 Months, 36 Months, 48 Months, 60 Months)
- Number of Participants With Aneurysm Expansion(12 Months, 24 Months, 36 Months, 48 Months, 60 Months)
- Number of Type Ia Endoleaks(Up to Five Years)
- Number of Type Ib Endoleaks(Up to Five Years)
- Number Endoleaks Type II(Up to Five Years)
- Number of Endoleaks Type IIIa(Up to Five Years)
- Number of Endoleaks Type IIIb(Up to Five Years)
- Number of Participants With Aneurysm Rupture(12 Months, 24 Months, 36 Months, 48 Months, 60 Months)
- Number of Patients With Endograft Occlusion(12 Months, 24 Months, 36 Months, 48 Months and 60 Months)
- Number of Participants With Device-Related Secondary Interventions(30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months)
- Number of Patients With Adjunctive Procedures(Intraprocedural)