ALTo endogrAft Italian Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Technical success
研究概览
简要总结
The aim of present study is to evaluate intraoperative, peri-operative, and post-operative results in patients treated by the ALTO stent graft (Endologix Inc. Irvine, Calif) for elective Abdominal Aortic Aneurysm repair in a multicentric consecutive experience.
详细描述
Thirty years ago, Juan Parodi developed the first prototype of endograft for Endovascular Aneurysm Repair, a handmade device made of a tube-shaped aorto-aortic graft sutured at each end to a balloon-expandable stent based on the design of radiologist Julio Palmaz. This device was implanted in a human body for the first time on September 7, 1990, in Buenos Aires, Argentina. By 1994, the first commercially available devices had been launched onto the market. Stent-graft material and design changed in various ways to improve conformability, reduce fracture, and minimize device migration rates. Over the years Endovascular Aneurysm Repair has become an effective treatment of AAA in challenging anatomy as hostile neck and small access. These performances have been achieved thanks to continuous technological development to overcome the previous limitation in Endovascular Aneurysm Repair applicability. Since 2010, the Ovation Abdominal Stent Graft System (Endologix Inc. Irvine, Calif) has offered a new concept of sealing, achieved by a network of O-rings filled with a polymer that can treat a great variety of difficult anatomies through a low-profile platform. In the latest version of the stent-graft, called Ovation Alto, the conformable O-rings with CustomSealTM polymer have been repositioned near the top of the endograft, providing a seal just below the renal arteries. Very few papers were published highlighting the early and late outcomes of this new device. In this perspective, this study is intended to be the first multicenter prospective registry regarding the implantation of Alto stent graft.
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
- •Elective AAA patients that should be treated by standard EVAR, according to Endologix Alto endograft device's Instructions For Use;
- •Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study;
- •Patient is >18 years old;
- •Patient, or their legal representative, understands the nature of the procedure and provides written informed consent, prior to enrollment in the study.
排除标准
- •EVAR performed in Urgent/Emergent setting;
- •Patients treated outside Endologix Alto endograft device's Instructions For Use;
- •Patients refusing treatment;
- •Patients for whom antiplatelet therapy, anticoagulants or antihypertensive drug are contraindicated;
- •Patients with a history of prior life-threatening contrast medium reaction;
- •Life expectancy of less than follow-up period.
- •AAA: abdominal aortic aneurysm; EVAR: abdominal endovascular aneurysm
结局指标
主要结局
Technical success
时间窗: 5 years
correct graft deployment without any unintentional occlusion of the aortic visceral branches and/or both hypogastric arteries, with aneurysm exclusion confirmed by the intraoperative angiography, without signs of type I/III endoleak a conversion to open surgery.
Clinical success
时间窗: 5 years
Successful deployment of the endovascular device at the intended location without death as a result of aneurysm-related treatment, type I or III endoleak, or graft infection or thrombosis, aneurysm expansion (\>5 mm), aneurysm rupture, or conversion to open repair. Moreover, the presence of graft dilatation of 20% or more by diameter, graft migration, or a failure of device integrity.
次要结局
- Operative time(Immediately after the procedure)
- Radiation exposure(Immediately after the procedure)
- Abdominal Aortic Aneurysm Shrinkage(5 year)
- Contrast medium usage(Immediately after the procedure)
研究者
Gianmarco de Donato
Associate Professor
Azienda Ospedaliera Universitaria Senese