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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The TrackCath System is a non-implantable device and consists of the TrackCath Catheter and the TrackCath Equipment. It is designed to support the successful positioning of third-party guidewires and catheters in the arterial vasculature to detect and cannulate side branches during endovascular aneurysm repair procedures through the measurement of real-time blood flow velocity changes.
Universitätsklinikum RWTH Aachen
Aachen, Germany
Heinrich-Heine University Düsseldorf
Düsseldorf, Germany
Universitäres Herzzentrum Hamburg
Hamburg, Germany
Universitätklinikum Leipzig
Leipzig, Germany
Procedural Success Rate
Successful TrackCath delivery of the distal end of the guidewire or of the 4 French catheter to the selected targeted orifice(s).
Time frame: Intra-operative
Primary Safety (All SADEs)
Occurrence of Serious Adverse Device Effects (SADE)
Time frame: Up to discharge (expected to be within 1 month)
Secondary Safety (All AEs)
All Adverse Events
Time frame: Up to discharge (expected to be within 1 month)
Procedural Parameters (contrast dye)
Amount of contrast dye used (ml)
Time frame: Intra-operative
Procedural Parameters (procedural times)
Exposure time to X-ray (min); total duration of the procedure (min); duration of the target orifice identification and cannulation (min).
Time frame: Intra-operative
Procedural Parameters (Blood flow velocity)
Blood flow velocity changes between above orifice and at orifice (m/s).
Time frame: Intra-operative
Surgeon satisfaction rate
Surgeon satisfaction on the use of the TrackCath catheter and the Blood Flow Velocity sensor, expressed on a scale from 1 (very bad) to 5 (very good).
Time frame: Intra-operative
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