A Phase II, Single-arm, Prospective Study of the Safety of the UniFit Aorto-uni-iliac Endoluminal Stent Graft for the Repair of Abdominal Aortic Aneurysms
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 71
- 试验地点
- 38
- 主要终点
- Primary Objective
研究概览
简要总结
The primary study objective, at this time, is to follow out to 5 years post implant the safety of already enrolled subjects who were treated with the UniFit Aorto-uni-iliac (AUI) Endoluminal Stent Graft (the "study device") for the repair of abdominal aortic aneurysms (AAAs).
详细描述
This is a phase II, single-arm, prospective study of the safety of the study device for the repair of AAAs.
The investigator will identify eligible patients and explain the study and study device placement procedure to each patient and/or any available family members. Patients who provide written informed consent will be evaluated for study eligibility within the time period identified under Duration of Treatment. Patients who are confirmed to be eligible, based on screening assessment findings, will be enrolled in the study.
After hospital discharge, patients will attend study center visits at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post-procedure for follow-up evaluations.
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
- 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 or older
- •Patient has a AAA that meets one of the following criteria:
- •Aneurysm diameter of greater than 4.5 cm, or less than 4.5 cm with rapid expansion
- •The aneurysm has a saccular configuration where potential for rupture is increased or has exhibited dissection with potential for rupture at, or compromised flow to, vital structures
- •The vessels immediately proximal and distal to the lesion are capable of accommodating the study device
- •The access artery diameter and profile of the artery are capable of study device delivery.
- •Patient has proximal and distal neck lengths of greater than or equal to 1.0 cm
- •Patient is willing and able to comply with the follow-up regime.
- •Patient has provided written informed consent.
排除标准
- •Patient has an aortic diameter greater than 36 mm.
- •Patients with ASA score less than 3 and deemed low risk by the Investigator for open surgical repair.
- •Patient has an indispensable inferior mesenteric artery.
- •Patient has a distal landing zone of < 2 cm in length or > 16 mm in diameter
- •Patient has iliac arteries whose tortuosity prevents passage of the introducer catheter.
- •If female, patient is pregnant
- •Patient has a life expectancy less than two years.
- •Patient has an allergy to any of the study device materials
- •Patient has coagulopathy or bleeding disorders
- •Patient for whom contrast medium or anticoagulation drugs are contraindicated
- •Patient has an uncontained rupture of the aneurysm.
- •Patient has an active systemic or localized groin infection
- •Patient has a connective tissue disease.
- •Patient has a GFR < 30 ml/min/1.73m2
- •Patient has a circumferential mural thrombus at the implantation site.
- •Patient is a candidate for a bifurcated endovascular graft.
- •Patient has an aortic trunk with an angle greater than 90°.
结局指标
主要结局
Primary Objective
时间窗: 5 year
The primary objective, at this time, is to ensure the safety of already enrolled and treated subjects. The data resulting from this study will not be used for any regulatory or commercialization purpose. The current sponsor, Duke Vascular, Inc. is requesting closure of this IDE
次要结局
未报告次要终点