NCT03165279

ZEnith AlPHa for AneurYsm Repair

ZEnith AlPHa for AneurYsm Repair (ZEPHYR)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 354 (actual)
• Sponsor: Philippe Cuypers · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The ZEPHYR registry has two major objectives: 1. 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. 2. 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.

Conditions

• Aneurysm

Interventions

Type	Name	Description
PROCEDURE	Zenith Alpha Abdominal stentgraft

Timeline

• Start date: 2016-12-07
• Primary completion: 2022-05-01
• Completion: 2022-07-01
• First posted: 2017-05-24
• Last updated: 2022-07-20

Locations

12 sites across 3 countries: Belgium, Germany, Netherlands