ZEnith AlPHa for AneurYsm Repair (ZEPHYR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 354
- 试验地点
- 12
- 主要终点
- Successful treatment
研究概览
简要总结
To prospectively collect 'real world' performance data on the Zenith AlphaTM Abdominal Endovascular Graft for endovascular aneurysm repair, inside and outside instructions for use. To assess clinical efficacy of the low-profile device to treat patients with abdominal aortic aneurysm (AAA), to assess the use of the new delivery and deployment system of the Zenith AlphaTM Abdominal Endovascular Graft. Primary endpoint is the proportion of subjects who experience successful treatment at 1 year post-implant; defined by technical success and clinical success.
详细描述
The ZEPHYR registry has two major objectives:
- to prospectively collect 'real world' safety, durability and clinical performance data on the Zenith AlphaTM Abdominal Endovascular Graft in subjects with infrarenal abdominal aortic or aorto-iliac aneurysms.
- To increase the clinical evidence about the safety and effectiveness of the Zenith AlphaTM Abdominal Endovascular Graft by creating a database that can be pooled and/or compared with databases available on this and other stent graft systems.
The ZEPHYR registry is a multi-center, post-market, non-randomized, single-arm prospective study. The study has no controls, as it is descriptive in nature. It will recruit approximately 450 subjects from high-volume sites across Germany and the BeNeLux. Study is open to consecutively enrolled subjects (20-50 per site) whou in the opinion of the investigator are candidates for endovascular AAA repair. The sites are recommended to schedule the subject's post-operative follow-up visits based on the current standard care in endovascular aneurysm repair (EVAR) therapy, which is generally at 1 month, 1 year and annually thereafter.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age ≥18 years or minimum age as required by local regulations
- •Non-ruptured AAA with maximum diameter ≥50mm or enlargement >5mm over 6 months and neck length ≥10mm (site-reported)
- •Elective EVAR
- •Intention to electively implant the Zenith AlphaTM AAA Endovascular Graft
- •Signed informed consent form
排除标准
- •Intolerance to contrast media
- •High probability of non-adherence to physician's follow-up requirements
- •Current participation in a concurrent trial which may confound study results
结局指标
主要结局
Successful treatment
时间窗: 1 year
Proportion of subjects who experience successful treatment at 1 year post-implant; defined by technical success and clinical success.
次要结局
- Treatment success(2 years)
- All-cause mortality(at 1 month, 1 year and at 2 years)
- Endoleak(at initial procedure, 1 month, 1 year and at 2 years)
- Amount of secondary procedures to correct endoleaks(From the day after the initial procedure up to 2 years after the initail procedure (which is the end of the follow up period for this registry))
- Amount of secondary procedures for occlusion and/or kinking to restore stent graft function (endovascular and open procedures)(From the day after the initial procedure up to 2 years after the initail procedure which is the end of the follow up period)
- Amount of secondary surgical interventions for stent graft infection(From the day after the initial procedure up to 2 years after the initail procedure which is the end of the follow up period)
- Amount of major lower limb amputation(From the day after the initial procedure up to 2 years after the initail procedure (which is the end of the follow up period for this registry))
- Which kind of vascular access is used during surgical intervention(at the primary procedure)
- Access site complications(during procedure up to 45 days)
- Amount of secondary open surgical interventions(From the day after the initial procedure up to 2 years after the initail procedure (which is the end of the follow up period of this registry))
- Major adverse events(at 1 month, 1 year and at 2 years)
- Aneurysm related mortality(up to 30 days after index procedure or within 30 days after aneurysm-related reintervention)
- Stent graft migration of >5mm (with 30 days measurement as baseline)(at 1 year and at 2 years)
研究者
Philippe Cuypers
MD, PhD
Catharina Ziekenhuis Eindhoven