Ignite Creation Date:
2024-05-06 @ 10:07 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03165279
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2017-05-16
Brief Title:
ZEnith AlPHa for AneurYsm Repair
Sponsor:
Philippe Cuypers
Organization:
Catharina Ziekenhuis Eindhoven
Study Overview
Official Title:
ZEnith AlPHa for AneurYsm Repair ZEPHYR
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZEPHYR
Brief 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 andor 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 subjects 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
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 andor 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 subjects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None