Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04765176
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-01-17
First Post:
2021-02-18
Brief Title:
A PMCF Study in Patients With Infrarenal Aortic Aneurysm Treated With the E-tegra Stent Graft System
Sponsor:
JOTEC GmbH
Organization:
JOTEC GmbH
Study Overview
Official Title:
A European Post-Market Clinical Follow-up Study PMCF in Patients With Infrarenal Aortic Aneurysm Undergoing Endovascular Stenting With the E-tegra Stent Graft System
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
EASY
Brief Summary:
The EASY post-market clinical follow-up study is undertaken to demonstrate safety and clinical performance of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm
Detailed Description:
In this study patients will be observed who receive an E-tegra Stent Graft for the treatment of infrarenal aortic aneurysm The E-tegra Stent Graft will be implanted at the discretion of the treating physician
Participating physicians will provide their observations collected during routine care for patients they have decided to treat with the E-tegra stent graft Informed consent of the patients to the use of their clinical records for study purposes will be obtained before their data will be collected in the post-market clinical follow-up study All patients will be asked to complete questionaires focussing on the health status HS SF-12 and Quality of Life QoL WHOQOL-BREF
The period of data collection will be approximately 60 months from the date of intervention for each patient Source document verification will be performed on 100 of the patients data from all visits will be reviewed and verified against existing source documents Complete DICOM image files of the CT scans as well as other imaging files eg CEUS MRT will be sent to a CoreLab for independent second evaluation There is no CoreLab screening before inclusion All adverse events defined prior to study start will be adjudicated by the Clinical Evaluation Committee CEC
Participating physicians will provide their observations collected during routine care for patients they have decided to treat with the E-tegra stent graft Informed consent of the patients to the use of their clinical records for study purposes will be obtained before their data will be collected in the post-market clinical follow-up study All patients will be asked to complete questionaires focussing on the health status HS SF-12 and Quality of Life QoL WHOQOL-BREF
The period of data collection will be approximately 60 months from the date of intervention for each patient Source document verification will be performed on 100 of the patients data from all visits will be reviewed and verified against existing source documents Complete DICOM image files of the CT scans as well as other imaging files eg CEUS MRT will be sent to a CoreLab for independent second evaluation There is no CoreLab screening before inclusion All adverse events defined prior to study start will be adjudicated by the Clinical Evaluation Committee CEC
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