Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04190979
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2019-11-14
Brief Title:
Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms AAA
Sponsor:
Medyria AG
Organization:
Medyria AG
Study Overview
Official Title:
Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms AAA - A Prospective Multi-centre Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-12
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:
ACCESS
Brief Summary:
Pre-market single-arm prospective open-label multi-center clinical trial aimed at assessing the safety and the performance of the Medyria TrackCath system in patients undergoing endovascular intervention
Detailed Description:
Pre-market single-arm prospective open-label multi-center clinical trial aimed at assessing the safety and the performance of the Medyria TrackCath system in patients above the age of 18 years who have been diagnosed with aneurysms in the thoracoabdominal TAAA or abdominal AAA aorta and require endovascular intervention
The TrackCath System is a non-implantable disposable device intended to measure real-time changes in the Blood Flow Velocity and to provide a pathway for delivering third-party guidewires andor catheters
Following patient consent data is collected until discharge
To reach 80 power a total number of 32 patients minimum 42 target orifices is scheduled including a minimum of 8 roll-in patients for the training phase which comprises at least two successful cases per center
The TrackCath System is a non-implantable disposable device intended to measure real-time changes in the Blood Flow Velocity and to provide a pathway for delivering third-party guidewires andor catheters
Following patient consent data is collected until discharge
To reach 80 power a total number of 32 patients minimum 42 target orifices is scheduled including a minimum of 8 roll-in patients for the training phase which comprises at least two successful cases per center
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