ZEnith AlPHa for AneurYsm Repair (ZEPHYR)

Philippe Cuypers

Status: Completed

Conditions: Aneurysm

Treatments: Procedure: Zenith Alpha Abdominal stentgraft

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT03165279

ZEPHYR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 354 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

354 participants in 1 patient group

Patient with AAA

Description:

Patient will receive a 'Zenith Alpha Abdominal stentgraft' as intervention to eliminate the abdominal aortic aneurysm.

Treatment:

Procedure: Zenith Alpha Abdominal stentgraft