ZEnith AlPHa for AneurYsm Repair

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.

Inclusion criteria

• 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

Exclusion criteria

• 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