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Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA) — ACCESS  

Acute Kidney Injury Clinical Trial

Official title:
Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA) - A Prospective Multi-centre Clinical Trial.

Clinical Trial 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.

Clinical Trial 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 and/or 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04190979
Study type Interventional
Source Medyria AG
Contact
Status Completed
Phase N/A
Start date March 17, 2018
Completion date February 25, 2019
View Details
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