JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Endologix
- 入组人数
- 450
- 试验地点
- 58
- 主要终点
- Neck Dilation in mm
研究概览
简要总结
Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints.
Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult age 21 and older
- •Subjects with minimum of 2 year life expectancy
- •Subjects have signed the informed consent document
- •Subjects with unruptured infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.
- •Patient must be able and willing to comply with all required follow-up exams.
排除标准
- •Currently participating in another trial where the primary endpoint has not been reached yet.
- •Known allergy to any of the device components
- •Pregnant (females of childbearing potential only)
- •Known connective tissue disorders
- •Known active infection
- •Subjects with pre-existing EVAR, i.e., in need of repair/intervention of a previously failed EVAR.
- •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.
研究组 & 干预措施
Alto Abdominal Stent Graft System
Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm.
干预措施: Alto Abdominal Stent Graft System (Device)
Comparators
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm.
干预措施: FDA Approved EVAR AAA Graft Systems (Device)
结局指标
主要结局
Neck Dilation in mm
时间窗: Through 5 years
Number of Participants with Freedom from Aneurysm-Related Complications (ARC)
时间窗: Through 5 years
Composite endpoint consisting of aneurysm-related death, aneurysm rupture, conversion to open surgery, type I and III endoleaks, device migration (\>10mm), aneurysm sac enlargement (\>5mm), occlusion, and freedom from device-related interventions
次要结局
- Count of participants All Cause Mortality(At 30 days, 12 months, and annually up to five years)
- Number of Type II(At 30 days, 12 months, and annually up to five years)
- Number of Major Adverse Events (MAEs)(At 30 days and 12 months)
- Number of Type Ib(At 30 days, 12 months, and annually up to five years)
- Count of subjects with occlusion(30 days, 12 months, and annually up to five years)
- Number of Participants with Freedom From device-related interventions(30 days, 12 months, and annually up to five years)
- Number of Type III(At 30 days, 12 months, and annually up to five years)
- Number of Unknown Enooleaks(At 30 days, 12 months, and annually up to five years)
- Count of participants with device migration (>10mm)(12 months, and annually up to five years)
- Count of participants AAA-related Mortality(At 30 days, 12 months, and annually up to five years)
- Number of Type Ia endoleaks(At 30 days, 12 months, and annually up to five years)
- Number of Type IV(At 30 days, 12 months, and annually up to five years)
- Count of participants with type I and III endoleaks(At 30 days, 12 months, and annually up to five years)
- Number of Secondary interventions(At 30 days, 12 months, and annually up to five years)
- Count of subjects lacking device integrity(At 30 days, 12 months, and annually up to five years)
- count of aneurysm ruptures(At 30 days, 12 months, and annually up to five years)
- Count of participants with conversion to open surgery(At 30 days, 12 months, and annually up to five years)
- Count of participants with aneurysm sac enlargement (>5mm)(12 months, and annually up to five years)